Sterrad or hydrogen peroxide based gas systems have not been validated. It is the physicians responsibility to determine the correct size of the Fusion Nail and Screws to be implanted. STERILIZATIONRecommended sterilization methods have been validated to sterility assurance levels (SAL) in compliance with federal and international standards. Keep instruments moist after use to prevent soil from drying on them. The use of this product is intended to be limited to persons trained in the procedure and knowledgeable of the inherent risks. Release the DynaNail Helix Threaded Bone Fastener from the Inserter Body Assembly by unscrewing the Connection Bolt. Indicates a medical device that has been sterilized using irradiation. High-end products that improve quality of life and restore movement. Scanning a patient who has this medical device may result in patient injury. [emailprotected], Your email address will not be published. Printed in the USA.Pat. In the US, users should only use sterilizers and accessories (such as sterilization wraps, sterilization pouches, chemical indicators, biological indicators, and sterilization containers) that have been clearly the US FDA for the selected sterilization cycle specifications (132C, 4 minutes). The DynaNail Deployment Frame and the Ancillary Surgical Instruments are provided NON-STERILE. Note: If you have questions concerning the disassembly of the instruments, contact the MedShape Customer Service or your local MedShape sales representative. SterilizationRecommended sterilization methods have been validated to sterility assurance levels (SAL) in compliance with federal and international standards. Instruments should be cleaned as soon as reasonably practical after use, according to the healthcare facilitys infection control and hazardous waste management procedures. Patients with conditions that restrict his or her ability or willingness to follow postoperative instructions during the healing process. Designed for use in subtalar fusion procedures, the DynaNail Hybrid contains an Superelastic Internal NiTiNOL Element that maintains active, dynamic compression in response to bone settling or resorption. Potential adverse effects resulting from the use of the DynaNail Mini Fusion System include, but are not limited to, the following: Adverse effects may necessitate reoperation, revision or removal surgery and/or amputation of the limb. The physician should always have a full inventory of sterile DynaNail TTC Fusion Nails and DynaNail Screw sizes on hand at the time of surgery to ensure the availability of the optimum size for the patient. Do not use device if it appears defective, damaged or otherwise compromised.The DynaNail Helix Fixation System is intended to facilitate healing but is not designed to support the patients body weight in the presence of a delayed union or nonunion of bone. Confirm that any moving parts function properly. Alternate fixation methods should also be available for use in the event that the DynaNail Mini Fusion System cannot be successfully implanted. Ensure that all blood, saline, and traces of tissue are removed. Follow the manufacturers instructions for mixing, preparing, and using such detergents. To place the proximal screw, follow the instructions in Steps 2 and 3, this time placing the Guide Sleeve and accompanying instrumentation through the proximal side hole of the Deployment Frame to drill a pilot hole through the proximal screw hole in the Fusion Nail. Proximal talar threads allow for easy insertion, similar to a screw. The DynaNail Mini Fusion Nail includes nickel and titanium materials. According to the Association for the Study of Internal Fixation principles, compression across a fusion site promotes bone healing and also provides . Use care in handling and storage of the instruments. Recommended Steam Sterilization ParametersTime and temperature parameters required for sterilization vary according to type of sterilizer and cycle design. The DynaNail TTC Fusion Nail, DynaNail End Cap, and DynaNail Screws are provided sterile for single use only. The safety of DynaNail Helix Fixation System in the MR environment is unknown. *With the Guide Sleeve placed through the appropriate distal side hole of the Nail Targeting Assembly and abutted to the bone surface, use the Drill Guide and Transverse Screw Drill to drill a pilot hole through the distal screw hole in the DynaNail Mini Implant. If any of the components are damaged during attempted placement, additional sterile components of the same size should be available. Packaged and sterilized instruments should be stored in an area that provides protection from dust, moisture, insects, vermin, and extremes of temperature and humidity. Use of the implant or system components for these purposes may result in patient injury. Longer lengths to accommodate the midfoot anatomy: 110-140 mm Maintains up to 6 mm of post-operative active compression PLUS intra-operative manual compression If the sterile packaging is found to be damaged or open, do not use the device or attempt to re-sterilize. All rights reserved. The DynaNail Mini is provided with the NiTiNOL Element pre-stretched and pre-loaded on a disposable Nail Guide. 7. These guidelines are not intended for DJO implants or single-use disposable instruments only for reusable instruments that are supplied non-sterile but are intended to be used in a sterile state. Remove the temporary compression drill and insert a 5mm Cortical Headed Screw. imperii Mini SPY Earpiece Instruction Manual, Novlistve 880788509328 Wireless Earbuds Bluetooth Headphones, NEC NP-M322W Smart Digital Projector Users Manual, SOLAX 0148083 BMS Parallel Box-II for Parallel Connection of 2 Battery Strings Installation Guide, LEDVANCE G11151664 Emergency Conversion Box Instruction Manual, havit SMART26 26 Keys Bluetooth Number Pad User Manual, EMERIL LAGASSE FAFO-001 French Door Air Fryer 360 Owners Manual, 10Gtek WD-4503AC Wireless Adapter Installation Guide, THETFORD SANICON Turbo 700 Owners Manual, FLOOR POLICE 15262-6 Cordless Electric Spinning Microfiber Flat Mop Instruction Manual. The DynaNail Mini Fusion System is designed for use in subtalar fusion and medial column fusion as well as the fusion of other large bones in the foot and ankle. Featuring MedShape's patented superelastic nickel titanium (NiTiNOL) technology, the DynaNail Mini is the first orthopaedic device designed specifically for subtalar fusion that offers maintained . The DynaNail Mini represents the latest innovation in the DynaNail product line to feature an internal NiTiNOL Compressive Element. Achieves 6 mm of post-operative compression PLUS 6 mm of intra-operative manual compression Provides automatic dynamization upon weightbearing The appearance of bubbles confirms the presence of protein and the instrument should be re- cleaned. Patients with an obliterated medullary canal or other conditions that tend to retard healing such as blood supply limitations or previous infections. Patients with an insufficient plantar pad. Misuse, mishandling and/or improper operation. If any of the components are damaged during attempted placement, additional sterile components of the same size should be available. Irritational injury of soft tissues, including impingement syndrome. Once the Fusion Nail, End Cap, and Screws have been removed from the packaging, the device should be either used or discarded. Contact DJO customer service for replacements. Gravity displacement sterilization is not recommended due to extended cycle times. Drill a hole in at least one of the proximal tibial holes across the DynaNail Implant and insert a 5mm Headed Cortical Screw1. Comment * document.getElementById("comment").setAttribute("id","aa0031aceadd6ff5ff5e8761e89208bc");document.getElementById("afe6277d1c").setAttribute("id","comment"); Save my name, email, and website in this browser for the next time I comment. Use only DynaNail TTC Fusion System components. Scanning a patient who has this device may result in patient injury. The patient should not have unrealistic expectations regarding the results that the surgery and implant may provide. Systemic or metabolic disorders or replacement. The DynaNail Helix Threaded Bone Fastener is manufactured from nickel titanium alloy and titanium alloy (Ti6Al-4V ELI) and is available in multiple lengths. This new classification will enable healthcare providers and payers to selectively track the utilization, outcomes and healthcare costs associated with this unique class of NiTiNOL compression technology. Patients with an active local or systemic infection. and sterilized prior to surgical use. Damage to the implants surface finish may result in loss of proper mechanical function of the device. Refer to Table A for further cleaning instructions. Neither DJO, LLC nor any of the Enovis companies dispense medical advice. If the sterile packaging is found to be damaged or open, do not use the device or attempt to resterilize. Visually inspect all instruments for any remaining debris prior to sterilization. Refer to Table A for manual cleaning steps. Inspect all components preoperatively to ensure that the device components and instruments are appropriate for use. FDA-cleared medical-grade steam sterilization compatible wrap that has been validated to allow sterilant penetration and subsequently maintains sterility. These guidelines are not intended for MedShape implants or single-use disposable instruments only for reusableinstruments that are supplied non-sterile but are intended to be used in a sterile state. Just connect the Nail Guide to the Mini Targeting Frame and implant! The DynaNail TTC Fusion System is designed for use in tibiotalocalcaneal (TTC) fusion, or hindfoot fusion, procedures to address degenerative conditions, correct joint deformities and revise failed total ankle replacements or arthrodesis non-unions. The patient should be informed that the life expectancy of the device is unpredictable once implanted and that successful results cannot be guaranteed. To detect any residual blood or protein particulates that may be trapped in visually obstructed areas, the instrument may be submerged in a 2% hydrogen peroxide solution. The surgeon is responsible for patient selection. Ensure that thepack is large enough to contain the instrument without stressing theseals. All cleaning and sterilization of the DynaNail. Return ConditionsIn the event the device must be returned for any reason, return the product in the original packaging. NiTiNOL-based DynaNail products approved for use with new ICD-10-PCS code. Call your DJO sales representative for a replacement. Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and. Patients with an insufficient quantity or quality of bone to permit fusion of the joints or stabilization of the arthrodesis. Moist heat/Steam is the only method that has been validated for reprocessing by MedShape. Limited Liability:The DynaNail TTC Fusion Nail, DynaNail End Cap, and the DynaNail Screws are guaranteed for materials, function, and workmanship for single patient use. NOTE: Synonyms for batch code are lot number and batch number.. 4. :http://www.medshape.com/patents.htmlMK-10161 Rev. Background The contents of this website do not constitute medical, legal, or any other type of professional advice. The patient should not have unrealistic expectations regarding the results that the surgery and implant may provide. Patients with an insufficient quantity or quality of bone to permit fusion of the joints or stabilization of the arthrodesis. Inspect all components preoperatively to ensure that the device components and instruments are appropriate for use. Internal NiTiNOL element offers between 2 - 5 mm of Repairs or modifications performed other than by DJO or a DJO authorized repair facility. The patient should be provided with detailed written instructions regarding postoperative care and theuse and limitations of the device. Never attempt to reuse. Follow the manufacturers instructions for mixing, preparing, and using such detergents. Use care in handling and storage of the instruments. DMP 711 Zone Expander Module . Containment devices can be stacked forstorage. Patients with an obliterated medullary canal or other conditions that tend to retard healing such as blood supply limitations or previous infections. Patients with severe longitudinal deformity. The DynaNail Mini is provided with the NiTiNOL Element pre-stretched and pre-loaded on a disposable Nail Guide. Use only DynaNail Helix Fixation System components. In the absence of a bursa or pain,removal of the implant in elderly or debilitated patients is not recommended. Damage to the implants surface finish may result in loss of proper mechanical function of the device. Unwillingness to accept the possibility of multiple surgeries for revision or replacement. In the case of very small dimension cannulations, a wire can be used to ensure that foreign material has been removed from the cannulation. active compression, PLUS manual intraoperative compression. Do not add other instruments to the DynaNail Instrument Caddy that are not part of the standard configuration supplied by MedShape. The quality of water should be carefully considered for use in cleaning reusable devices. Prolonged exposure to saline may result in corrosion of stainless steel instruments. FDA-cleared medical grade steam sterilization compatible wrap that has been validated to allow sterilant penetration and to subsequently maintain sterility. It is the physicians responsibility to determine the correct size of the DynaNail Helix Threaded Bone Fastener and DynaNail Helix Washer to be implanted. Validated exposure time required to achieve a 10-6 sterility assurance level (SAL). End of life is normally determined by wear and damage due to use. Containment devices can be stacked for storage. The patient should be encouraged to report to his/her surgeon any unusual changes to the operated extremity. The DynaNail Helix Fixation System has not been evaluated for safety and compatibility in the MR environment. Gravity displacement sterilization is not recommended due to extended cycle times. Post-traumatic or primary arthrosis involving both ankle and subtalar joints. The physician should always have a full inventory of sterile Fusion Nails and Screw sizes on hand at the time of surgery to ensure availability of the optimum size for the patient. Resterilization may result in loss of proper mechanical function of the device and could result in patient injury. The DynaNail Mini represents the latest innovation in the DynaNail product line to feature an internal NiTiNOL Compressive Element. DJO Wrist and Finger Undersleeve Instruction Manual, MAYTAG 4.5 Cu. Cannulated portions should be cleaned with a soft-bristled nylon brush, pipe cleaner, or appropriately sized guidewire. The surface of the implant must always be protected from damage during handling. Carefully inspect product packaging and all device components for damage or defects prior to use. Pain, discomfort, or abnormal sensations due to the presence of the implant. Where material sensitivity is suspected, appropriate tests should be conducted and sensitivity ruled out prior to implantation. Do not rely upon automated cleaning using a washer/disinfector alone as this may not be effective for devices and instruments with cannulations, blind holes, mated surfaces and other complex features. Use in any manner or medical procedure other than those for which it is designed; and any special, indirect, and/or consequential damages of any kind and however caused arising from the sale or use of the product. The DynaNail Mini Fusion System is an innovative intramedullary nail system designed for use in subtalar fusion procedures and other large bone fusion procedures. Discard blunt or damaged instruments. pH neutral detergent. Ideally, all components should be cleaned within 30 minutes and after no more than 4 hours of use to minimize the potential for saline, blood, body fluids, tissue, bone fragments or other organic debris to dry on the instrument prior to cleaning. Deployment Frame and Ancillary Surgical Instruments should be carried out by proficient personnel following appropriate healthcare facility procedures. The DynaNail TTC Fusion System is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine. The surgeon is responsible for understanding the appropriate indications and contraindications associated with the device and selecting the surgical procedures and techniques determined to be best for each individual patient. Please review the instructions of the sterilizer, manufacturer, or healthcare facility procedures prior to sterilization. central supply room wrap (CSR), paper/plastic pouches, rigid containers, etc.) These specialized instruments are required to correctly perform the DynaNail Helix implantation procedure and to remove the DynaNail Helix Threaded Bone Fastener and DynaNail Helix Washer if required, following implantation. Required fields are marked *. Failure to immobilize the site during healing may result in bending and/or breakage of the device and/or failed fusion. Manual cleaning should be done while the instrument is immersed. Use flowing water and disposable wipes to remove excess soil. Patients with an obliterated medullary canal or other conditions that tend to retard healing such as blood supply limitations or previous infections. The physician should always have a full inventory of sterile DynaNail Helix Threaded Bone Fasteners and DynaNail Helix Washers on hand at the time of surgery to ensure availability of the optimum size for the patient. Take care to place difficult-to-clean parts near the center of the rack, open-side down, minimizing touching between parts. The DynaNail TTC Fusion Nail, DynaNail End Cap, and the DynaNail Screws are implanted into the medullary canal of the tibia, talus, and calcaneus using the DynaNail Deployment Frame and Ancillary Surgical Instruments. Each Ancillary Surgical Instrument must be properly cleaned and sterilized prior to first use and before each subsequent use in accordance with the guidelines provided herein. Hybrid screw/nail design of the DynaNail Hybrid combines sustained dynamic compressive power with easy, intuitive insertion. DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile : Code Information: Model No. 1 (5): 1-8. The worldwide leading provider of diabetic footwear. 5. Refer to Table A for manual cleaning steps. Damage to the implants surface finish may result in loss of proper mechanical function of the device. In order to make an informed decision, the patient should clearly understand all applicable warnings, precautions, possible intraoperative and postoperative complications, and possible adverse effects associated with the surgical procedure and implantation of the device. The DynaNail Helix Threaded Bone Fastener is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine. Patients with conditions that restrict his or her ability or willingness to follow postoperative instructions during the healing process. Implant removal should be followed by adequate postoperative management to avoid fracture or refracture. 6 mri safety information. Dupont KM, Shibuya N, Bariteau JT. Never attempt to reuse. We and our partners use cookies to Store and/or access information on a device.We and our partners use data for Personalised ads and content, ad and content measurement, audience insights and product development.An example of data being processed may be a unique identifier stored in a cookie. Demonstrated psychological instability, inappropriate motivation or attitude. Patients with severe peripheral vascular disease. The DynaNail Hybrid shares universal instrumentation with the DynaNail Mini to provide surgeons with intraoperative ease and flexibility. Hear from patient Teri Sutherland about her experience and recovery after undergoing a procedure with MedShape's DynaNail Mini. Rigid sterilization container that complies with ANSI/AAMI ST46. Careful preoperative planning must be conducted based on radiographic findings. Patients should be cautioned against unassisted activity that requires walking or lifting. The Screws are manufactured from titanium alloy (Ti 6Al-4V ELI) and are available in a range of lengths. Use only DynaNail Mini Fusion System components. Unwillingness to accept the possibility of multiple surgeries for revision or replacement. Where material sensitivity is suspected, appropriate tests should be conducted and sensitivity ruled out prior to implantation. The DynaNail Mini Instrument Caddy is designed to hold the DynaNail Mini Deployment Frame and all of the Ancillary Surgical Instruments during sterilization. The use of abrasive compounds or excessively acidic or alkaline solutions may cause damage to the instruments and should be avoided.7. This newest version comes in longer lengths (110-140 mm) which offer better stability and post-operative NiTiNOl compression across the midfoot bone anatomy, according to the company. Following the presoak the instruments should be wiped or scrubbed using a brush, cloth or sponge that does not mar the surface of the instrument. Tibiotalocalcaneal Arthrodesis with Intramedullary Nails Mechanobiological Background and Evolution of Compressive Technology. Call your MedShape sales representative for a replacement. If evidence suggests loosening of the implant (particularly pain and/or progressive changes in the radiographs), an intensified schedule of check-ups is advised and new warnings and instructions to the patient may be necessary to further restrict activities.The patient should be encouraged to receive prompt medical attention for any infection that may occur, either at the surgery site or elsewhere in the body. Other sterilization cycles may also be suitable, but the individuals or hospitals are advised to validate other methods for use with MedShape products. It is important that adequate cleaning be carried out prior to sterilization. pipe cleaner, or appropriately sized guidewire. Previously infected arthrosis, second degree. MedShape, Inc.1575 Northside Drive, NW,Suite 440Atlanta, Georgia 30318USAT: 877-343-7016F: 877-343-7017www.medshape.com, DynaNail Mini is a registered trademark of MedShape, Inc. DynaNail Mini Hybrid is a trademark of MedShape, Inc.2019 MedShape, Inc. All rights reserved. Turn the Manual Compression Knob on the Deployment Frame to apply external manual compression. 9 informasi perencanaan preoperatif. *Not applicable to DynaNail Mini Hybrid Fusion Nail. Patients with an active soft tissue infection or osteomyelitis of foot and ankle. To minimize possible interference risks during medical imaging such as magnetic resonance imaging (MRI), advise the patient to mention that he/she was implanted with a metallic device. A thorough manual or combination manual/automated cleaning process is required. Return Conditions:In the event the device must be returned for any reason, return the product in the original packaging. The DynaNail Deployment Frame and each Ancillary Surgical Instrument must be properly cleaned and sterilized prior to first use and before each subsequent use in accordance with the guidelines provided herein. The DynaNailu00ae Mini Fusion System is implanted using the DynaNail Mini Deployment Frame and Ancillary Surgical Instruments. It is the physicians responsibility to determine the correct size of the DynaNail TTC Fusion Nail and DynaNail Screws to be implanted. The use of abrasive compounds or excessively acidic or alkaline solutions may cause damage to the instruments and should be avoided. The Ancillary Surgical Instruments should not be reused if visible deterioration such as corrosion or damage resulting from use or handling is evident. The DynaNail Mini Fusion System is an innovative intramedullary nail system designed for use in subtalar fusion procedures and other large bone fusion procedures. Store the Ancillary Surgical Instruments in the DynaNail Helix Instrument Tray. Irritational injury of soft tissues, including impingement syndrome. Contact Customer Service or an authorized MedShape representative to receive a return authorization number prior to return shipment. The DynaNail TTC Fusion Nail is intended to facilitate healing but is not designed to support the patients body weight in the presence of a delayed union or nonunion of bone. When utilizing an automated cleaner, follow equipment manufacturers instructions for use, incorporating a low foaming, pH neutral detergent. The DynaNail Mini Deployment Frame and the Ancillary Surgical Instruments are provided NON-STERILE. The Ancillary Surgical Instruments should be fully disassembled into component parts prior to cleaning. Additional MedShape Cleaning Instructions. DynaNail TTC Fusion System is designed for use in tibiotalocalcaneal (TTC) fusion, or hindfoot fusion, procedures to address degenerative conditions, correct joint deformities and revise failed total ankle replacements or arthrodesis non-unions. Cutting edges should be free of nicks and present a continuous edge. Bienvenue dans ce guide sur Aseprite et la cration d'asset 2D pour un mini RPG 2D en Pixel Art. ATLANTA, Sept. 3, 2019 /PRNewswire/ -- MedShape Inc., the industry leader in orthopedic devices using advanced functional materials, announced today the launch of the DynaNail Mini Fusion System. The DynaNail Mini is provided with the NiTiNOL Element pre-stretched and pre-loaded on a disposable Nail Guide. Offers between 2-4 mm of post-operative active compression PLUS intra-operative manual compression Provides strong joint stability due to maintained compression Patients with conditions that restrict his or her ability or willingness to follow postoperative instructions during the healing process. Any patient who cannot properly utilize weight support devices may be particularly at risk during postoperative rehabilitation. Careful preoperative planning must be conducted based on radiographic findings.Never attempt a surgical procedure with defective, damaged or otherwise compromised instruments or implants. If evidence suggests a loosening of the implant (particularly pain and/or progressive changes in the radiographs), an intensified schedule of check-ups is advised and new warnings and instructions to the patient may be necessary to further restrict activities. on MEDSHAPE DynaNail Mini Fusion System Instruction Manual, MEDSHAPE DynaNail Mini Fusion System Instruction Manual, 14. Until firm bony union is achieved, the patient should employ adequate external support and restrict physical activities that would place stress upon the implant or allow movement at the site and delay healing. We also use cookies to target our marketing to your needs. Some of the products advertised on this website may not be licensed in accordance with Canadian law. With the numbered Compression Wheelset to 0, fully stretch the Compressive Element by pulling down on the lever. The consent submitted will only be used for data processing originating from this website. The adequacy of any healthcare facility sterilization procedure must be suitably tested. THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS, IMPLIED, AND/OR STATUTORY, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY, FITNESS, AND/OR SUITABILITY FOR A PARTICULAR PURPOSE, AND OF ALL OTHER OBLIGATIONS OR LIABILITIES ON MEDSHAPES PART. In Sets: Load MedShape Surgical Instruments into the appropriateinstrument trays. Lacks an understanding that their preoperative capacity may not be fully recovered even after successful implantation. The Deployment Frame, Guide Sleeve, and appropriate Drill Guide may be used to target all drills/screws except for the most proximal hole on the 26 cm and 30 cm length DynaNail implants. Prior to implantation, patients should be counseled on the materials contained in the device, as well as potential for allergy/hypersensitivity to these materials. Always follow the sterilizer manufacturers recommendations. If evidence suggests loosening of the implant (particularly pain and/or progressive changes in the radiographs), an intensified schedule of check-ups is advised and new warnings and instructions to the patient may be necessary to further restrict activities. Until firm bony union is achieved, the patient should employ adequate external support and restrict physical activities that would place stress upon the implant or allow movement at the site and delay healing. All implants are sold sterile. Loosening, bending, cracking, or fracture of the implant components. Loosening, bending, cracking or fracture of the implant components. DO NOT ATTEMPT TO RESTERILIZE. Connect corresponding. The surgeon must make the final decision regarding implant removal. Some of our partners may process your data as a part of their legitimate business interest without asking for consent. In the case of very small dimension cannulations, a wire can be used to ensure that foreign material has been removed from the cannulation. Loss of anatomic positioning with nonunion or malunion with rotation or angulation. Lester ELECTRICAL ChargerConnect App User Guide, mXion PWD 2-Channel Function Decoder User Manual, amber connect ANC200 Instant C200 Cigarette Lighter GNSS Tracker User Guide, mXion RD6 6-Channel Relay Decoder User Manual, havit SMART26 26 Keys Bluetooth Number Pad User Manual, EMERIL LAGASSE FAFO-001 French Door Air Fryer 360 Owners Manual, 10Gtek WD-4503AC Wireless Adapter Installation Guide, THETFORD SANICON Turbo 700 Owners Manual, FLOOR POLICE 15262-6 Cordless Electric Spinning Microfiber Flat Mop Instruction Manual. Carefully inspect product packaging and all device components for damage or defects prior to use. 5 potensi efek samping. Store the DynaNail Mini Fusion System Components in a dry place at room temperature (20oC to 25oC). and sterilized prior to surgical use. Implant removal should be followed by adequate postoperative management to avoid fracture or refracture. The Fusion Nail , Continue reading MEDSHAPE DynaNail Mini Fusion System Instruction Manual, MEDSHAPE DynaNail Mini Fusion System Instruction Manual, on MEDSHAPE DynaNail Mini Fusion System Instruction Manual, MEDSHAPE DynaNail Mini Fusion System Instruction Manual, Hitachi CPAW3005 LCD Projector Users Manual, LG P1400RTM 14 KG Washing Machine Owners Manual, BOFIDAR Touch Screen Bluetooth Smartwatch Operational Guide, KICKER CXA360.4 4-Channel 490-Watts Class A-B Full-Range Car Audio Amplifier Owners Manual, PreSonus Studio 68c USB Audio Interface USER GUIDE, havit SMART26 26 Keys Bluetooth Number Pad User Manual, EMERIL LAGASSE FAFO-001 French Door Air Fryer 360 Owners Manual, 10Gtek WD-4503AC Wireless Adapter Installation Guide, THETFORD SANICON Turbo 700 Owners Manual, FLOOR POLICE 15262-6 Cordless Electric Spinning Microfiber Flat Mop Instruction Manual. Loss of anatomic positioning with nonunion or malunion with rotation or angulation. The DynaNail Mini Fusion System is indicated for fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of large bones in the foot and ankle. Absent talus (requiring talocalcaneal arthrodesis). Containment devices can be stacked for storage. Loosening, bending, cracking or fracture of the implant components. Primary responsible party for all manufacturing transfer responsibilities for new "Active Adaptive" products at MedShape (Enovis Atlanta Office) including DynaNail, DynaNail Mini and Hybrid, Helix . Has immunological responses, sensitization, or hypersensitivity to foreign materials. Rinse parts under cold (<45C) potable water for a minimum of one (1) minute. The DynaNail Miniu00ae Fusion System is designed for use in subtalar fusion and medial column fusion as well as the fusion of other large bones in the foot and ankle. PRECAUTIONSThe DynaNail Helix Fixation System should only be used by those physicians who have been trained in the appropriate, specialized procedures. Extreme care must be taken when following the technique for removal of the device. the dynanail mini fusion system in extended lengths was designed for use in midfoot reconstruction procedures and features patented and proven superelastic internal nitinol compressive element technology now miniaturized to accommodate smaller bone anatomy 2,3unlike traditional beaming devices that lose compression within 1 mm of bone Subtalar fusion surgery is performed to relieve pain and correct severe foot deformity by achieving a solid bony union. Rigid sterilization container that complies with ANSI/AAMI ST46. Use of the implant or system components for these purposes may result in patient injury. In order to make an informed decision, the patient should clearly understand all applicable warnings precautions, possible intraoperative and postoperative complications and possible adverse effects associated with the surgical procedure and implantation of the device. Systemic or metabolic disorders or replacement. Resterilization may result in loss of proper mechanical function of the device and could result in patient injury. The DynaNail Mini Fusion System features MedShape's patented superelastic nickel . It is the responsibility of the user to ensure that the sterilization process is actually performed using qualified equipment, materials, and personnel such that the recommended parameters are achieved. Therefore, it is important that immobilization of the site is maintained until firm bony union (confirmed by clinical and radiological examination) is established. Visually inspect all instruments for damage and wear. Once the DynaNail Helix Threaded Bone Fastener and DynaNail Helix Washer have been removed from the packaging, the devices should be either used or discarded. The adequacy of any healthcare facility sterilization procedure must be suitably tested. It has not been tested for heating, migration, or image artifact in the MR environment. Please remove any damaged device or instrument from use and call your MedShape sales representative for a replacement. If you would like to change your settings or withdraw consent at any time, the link to do so is in our privacy policy accessible from our home page. Additional DJO Cleaning Instructions. Refer to the Instrument Tray and/or illustration in DJO's Surgical Technique Guide for the completely . Instruments should be cleaned as soon as reasonably practical after use, according to the health care facilitys infection control and hazardous waste management procedures. The DynaNail Mini Fusion System is implanted using the DynaNail Mini Deployment Frame and Ancillary Surgical Instruments. Drying times vary according to load size and should be increased for larger loads. The surgeon is responsible for patient selection. Patients with foreign body sensitivity is suspected, or documented metal allergy or intolerance. Return Conditions:In the event, the device must be returned for any reason, return the product in the original packaging. Carefully select the appropriate DynaNail Mini Screw sizes based on the needs of each individual patient. Global J of Orthopedics Research, 2019. After implanting DynaNail, the Compressive Element is stretched 6 mm and fixed in the stretched position with two screws (one posterior-anterior and one lateral-medial) in the calcaneus allowing. All instruments should be thoroughly cleaned. Unwillingness to accept the possibility of multiple surgeries for revision or replacement. When evaluating patients for implantation using the DynaNail Helix Threaded Bone Fastener and DynaNail Helix Washer, always consider the patients weight, occupation, activity level and the presence of any degenerative disease. Repeat the process until no visible debris remains. Place your non-custom orders instantly and easily. DynaNail is a registered trademark of MedShape, Inc.MedShape, Inc., 2017. Implant removal should be followed by adequate postoperative management to avoid fracture or refracture. The latest addition to DJO's robust suite of foot and ankle products and an expansion of the DynaNail Mini line, the system leverages MedShape's proven active, adaptive healing technology 1 . Neuromuscular disease and severe deformity. Prior to surgery, the surgeon should discuss with the patient all possible risks versus potential benefits of treatment considering the patients preoperative condition and expectations for improvement in his/her condition postoperatively. The health care facility is responsible for maintaining water quality that is compliant with AAMI TIR34. MedShape's DynaNail Mini is designed for subtalar arthrodesis and other large bone foot and ankle fusions. Demonstrates physiologic or anatomic anomalies. Intraoperative fluoroscopy (C-Arm) should be available and utilized as required to confirm correct positioning of implantable DynaNail Mini Fusion System components. Failure to immobilize the site during healing may result in bending and/or breakage of the device and/or failed fusion. The DynaNail Helix Threaded Bone Fastener and DynaNail Helix Washer are provided sterile for single use only. Release the Fusion Nail from the Deployment Frame by unscrewing the connection screw. Do not rely upon automated cleaning using a washer/disinfector alone as this may not be effective for devices and instruments with cannulations, blind holes, mated surfaces, and other complex features. Potential adverse effects resulting from the use of the DynaNail Helix Fixation System include, but are not limited to, the following: Adverse effects may necessitate reoperation, revision, or removal surgery and/or amputation of the limb. Home DJO DJO DynaNail Helix Fixation System Instruction Manual. Single: A standard packaging material may be used. The surgeon is responsible for patient selection. Ft. White Top Load Washer User Guide, Fujifilm Finepix A900 9MP Digital Camera Owners Guide, LG HU80KA Smart CineBeam DLP Projector Owners Manual, havit SMART26 26 Keys Bluetooth Number Pad User Manual, EMERIL LAGASSE FAFO-001 French Door Air Fryer 360 Owners Manual, 10Gtek WD-4503AC Wireless Adapter Installation Guide, THETFORD SANICON Turbo 700 Owners Manual, FLOOR POLICE 15262-6 Cordless Electric Spinning Microfiber Flat Mop Instruction Manual. Therefore, it is important that immobilization of the site is maintained until firm bony union (confirmed by clinical and radiological examination) is established. The DynaNail Mini Fusion System is designed for use in subtalar fusion and medial column fusion as well as the fusion of other large bones in the foot and ankle. Rehabilitation, pain management and healing. Sterrad or hydrogen peroxide based gas systems have not been validated. DESCRIPTION. SterilizationRecommended sterilization methods have been validated to sterility assurance levels (SAL) in compliance with federal and international standards. Pain, discomfort, or abnormal sensations due to presence of the implant. Water hardness is a concern because deposits left on medical devices may result in ineffective cleaning or sterilization. Do not stack the DynaNail Helix Instrument Trays during sterilization. Recommended Steam Sterilization ParametersTime and temperature parameters required for sterilization vary according to the type of sterilizer and cycle design. Ideally, all components should be cleaned within 30 minutes, and after no more than 4 hours, of use to minimize the potential for saline, blood, body fluids, tissue, bone fragments, or other organic debris to dry on the instrument prior to cleaning. The physician must determine if the device is appropriate for patients having any of the following physical or emotional conditions: It is the responsibility of the surgeon to provide the patient with appropriate information prior to surgery. According to the Association for the Study of Internal Fixation principles . DynaNail Mini was introduced in 2019 with 60-100 mm lengths for use in subtalar fusion procedures. Demonstrated psychological instability, inappropriate motivation, or attitude. For more information visit us at https://www . Skeletally immature patients where the implant would cross open epiphyseal plates. DO NOT ATTEMPT TO RESTERILIZE. Persons with allergic reactions to these metals may suffer an allergic reaction to this implant. All cleaning should be performed in a manner designed to minimize exposure to bloodborne pathogens. Release the DynaNail Implant from the Deployment Frame by unscrewing the Connection Screw. Tibiotalocalcaneal Arthrodesis with Intramedullary Nails - Mechanobiological Background and Evolution of Compressive Technology. The DynaNail TTC Fusion System includes nickel and titanium materials. Please remove any damaged device or instrument from use and call your DJO sales representative for a replacement. Ancillary Surgical Instruments are required to complete the implant procedure and to remove the DynaNail. The patient should be informed that the life expectancy of the device is unpredictable once implanted and that successful results cannot be guaranteed. Contaminated instruments should be transported to the area for cleaning in a way that avoids contamination of personnel and hospital. The Ancillary Surgical Instruments are specifically designed for use with the DynaNail TTC Fusion System. Check final position of DynaNail Helix Fixation System implant(s) using fluoroscopy, close wounds, and end procedure. DynaNail Mini is a trademark of MedShape, Inc. DynaNail and DynaClip are registered trademarks of MedShape, Inc. 1 Dupont KM, Shibuya N, Bariteau JT. 2. Follow Universal Precautions for handling and transporting contaminated instruments to the designated cleaning area. Manage SettingsContinue with Recommended Cookies, Home MEDSHAPE MEDSHAPE DynaNail Mini Fusion System Instruction Manual, The DynaNail Mini Fusion System consists of the following components: Fusion Nail. A thorough manual or combination manual/automated cleaning process is required. It is critical that the appropriate process parameters be validated for each healthcare facilitys sterilization equipment and product/load configuration by persons who have training and expertise in sterilization processes to substantiate the process and its reliability and reproducibility. Handling of the Ancillary Surgical Instruments must be performed in accordance with aseptic handling practices to maintain sterility following sterilization by the healthcare facility. The DynaNail Deployment Frame and Ancillary Surgical Instruments must be placed in the designated location within the DynaNail Instrument Caddy. To learn more about what we collect and how we use that information, or to change your privacy settings see our Privacy Policy. It has not been tested for heating, migration, or image artifact in the MR environment. It is the responsibility of the user to ensure that the sterilization process is actually performed using qualified equipment, materials, and personnel such that the recommended parameters are achieved. Any patient who cannot properly utilize weight support devices may be particularly at risk during postoperative rehabilitation. The surgeon must make the final decision regarding implant removal. End of life is normally determined by wear and damage due to use. Each surgeon must evaluate the appropriateness of the device and the procedure used to implant the device based on his/her own training and experience. It is important that adequate cleaning be carried out prior to sterilization. DALLAS--(BUSINESS WIRE)--DJO, a subsidiary of Colfax Corporation (NYSE: CFX) and a leading global provider of medical technologies to get and keep people moving, today announced the launch of the MedShape DynaNail Hybrid Fusion System. Place all parts on a flat working surface. Store the DynaNail Helix Threaded Bone Fastener and DynaNail Helix Washer in a dry place at room temperature (20C to 25C). The DynaNail Mini Fusion System is the ONLY fusion approach that offers the compression performance of an external fixator inside an intramedullary nail. When sterilizing multiple sets, ensure that the manufacturers maximum load is not exceeded. Failure to do so may result in loosening, bending, cracking, or fracture of the device or injury to the patients bone or both. Reusable instruments should be placed in suitable packaging for the sterilization process (i.e. The healthcare facility is responsible for in-house procedures for the reassembly, inspection and packaging of the instruments after they are thoroughly cleaned in a manner that will ensure steam sterilant penetration and adequate drying. Place small parts in baskets to prevent dislodging. The healthcare facility isresponsible for maintaining water quality that is compliant with AAMI TIR34. For manual washing, MedShape recommends using cold demineralized or distilled water along with a neutral pH (7-8.5) enzymatic detergent. Packaged and sterilized instruments should be stored in an area that provides protection from dust, moisture, insects, vermin, and extremes of temperature and humidity. Patients with severe peripheral vascular disease. The DynaNail Mini Deployment Frame and Ancillary Surgical Instruments must be placed in the designated location within the DynaNail Instrument Caddy. Potential adverse effects resulting from the use of the DynaNail TTC Fusion System include, but are not limited to, the following: Adverse effects may necessitate reoperation, revision or removal surgery, and/or amputation of the limb. Contact Customer Service or an authorized DJO representative to receive a return authorization number prior to return shipment. The consent submitted will only be used for data processing originating from this website. The quality of water should be carefully considered for use in cleaning reusable evinces. The Ancillary Surgical Instruments must be placed in the designated location within the DynaNail Helix Instrument Tray. Handling of the DynaNail Mini Deployment Frame and the Ancillary Surgical Instruments must be performed in accordance with aseptic handling practices to maintain sterility following sterilization by the healthcare facility. The DynaNail TTC Fusion System should only be used by those physicians who have been trained in the appropriate, specialized procedures. According to ANSI/AAMI standard ST79:2010. the accepted standard for the degree of cleanliness is visibly clean. Prior to surgery, instruments should be fully inspected for any evidence of damage or corrosion. Contact Customer Service or an authorized MedShape representative to receive a return authorization number prior to return shipment. The DynaNail TTC Fusion Nail is manufactured from nitinol and titanium alloy (Ti 6Al-4V ELI) and is available in multiple diameters and lengths. Repairs or modifications performed other than by MedShape or a MedShape authorized repair facility.c. Do not use any device if it appears defective, damaged, or otherwise compromised. Limb shortening or loss of anatomic positioning with nonunion or malunion with rotation or angulation. The DynaNail Mini Deployment Frame and Ancillary Surgical Instruments are guaranteed to be free from defects due to materials or workmanship and have a one (1) year limited warranty.MedShape shall not be liable, expressly or implied for any damage which might arise or be caused, whether by the customer or by any of the users of the product, as a result of: THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS, IMPLIED, AND/OR STATUTORY, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY, FITNESS, AND/OR SUITABILITY FOR A PARTICULAR PURPOSE, AND OF ALL OTHER OBLIGATIONS OR LIABILITIES ON MEDSHAPES PART. Drug and/or alcohol and/or smoke addiction and/or abuse. Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself. Knowledge of appropriate surgical techniques, instrumentation, proper selection and placement of implants, and postoperative patient care and management are essential to a successful outcome. The DynaNail Mini Deployment Frame and each Ancillary Surgical Instrument must be cleaned in accordance with appropriate healthcare facility procedures prior to sterilization. 1. Confirm that any moving parts function properly. It is critical that the appropriate process parameters be validated for each healthcare facilitys sterilization equipment and product/load configuration by persons who have training and expertise in sterilization processes to substantiate the process and its reliability and reproducibility.Any recommendations provided herein are provided as general guidelines only. Tibiotalocalcaneal Arthrodesis with. The patient should be advised that noncompliance with postoperative instructions could lead to loosening, bending or breakage of the implant, requiring revision surgery to remove the device. Failure to do so may result in loosening, bending, cracking or fracture of the device or injury to the patients bone or both. 8. Visually inspect all instruments for any remaining debris prior to sterilization. Do not rely upon automated cleaning using a washer/disinfector alone as this may not be effective for devices and instruments with cannulations, blind holes, mated surfaces and other complex features. Rinse instruments following exposure to hydrogen peroxide. The Ancillary Surgical Instruments are specifically designed for use with the DynaNail Mini Fusion System. Sterrad or hydrogen peroxide-based gas systems have not been validated. 11 petunjuk penggunaan. Failure to do so may result in severe patient injury. The DynaNail Mini Fusion System components manufactured by MedShape must not be used in conjunction with screws, wire bands, or other metallic devices manufactured by any other manufacturer, as component parts may not be compatible. Has immunological responses, sensitization or hypersensitivity to foreign materials. Prior to surgery. Therefore, it is important that immobilization of the site is maintained until firm bony union (confirmed by clinical and radiologicalexamination) is established. The DynaNail Mini Fusion System is intended to facilitate healing but is not designed to support the patients body weight in the presence of a delayed union or nonunion of bone. central supply wrap (CSR), paper/plastic pouches, rigid containers, etc.) Always handle the DynaNail Helix Threaded Bone Fastener and DynaNail Helix Washer carefully. The End Cap is manufactured from titanium alloy (Ti 6Al-4V ELI). Consult Instructions For Use. No reassembly is necessary as the instruments remain in their fully disassembled form during cleaning and sterilization. DynaNail Helix comes with the NiTiNOL Element prestretched and pre-loaded on a disposable Nail Guide that connects directly to the ratcheting handle for easy insertion. Demonstrates physiologic or anatomic anomalies. The patient should be encouraged to receive prompt medical attention for any infection that may occur, either at the surgery site or elsewhere in the body. Gravity displacement sterilization is not recommended due to extended cycle times. Keep instruments moist after use to prevent soil from drying on them. NiTiNOL and its pseudoelastic properties have shown to be. Description. TABLE A. When sterilizing multiple sets, ensure that the manufacturers maximum load is not exceeded. Any recommendations provided herein are provided as general guidelines only. DynaNail Mini Fusion System - Subtalar Fusion Surgical Technique Guide. Do not modify the implant. Avoid contacting the implant with other tools or materials that could notch, scratch or otherwise damage the implant surface. Instruments should be cleaned as soon as reasonably practical after use, according to the health care facilitys infection control and hazardous waste management procedures. Use the Compression Wheel to dial in the desired amount of compression (1-6), depending upon surgeon preference. the dynanail mini fusion system features djo's patented and proven superelastic internal nitinol compressive element technology miniaturized for use in subtar fusion 2-4unlike traditional screws that lose compression within 1 mm of bone resorption, the dynanail mini is the only internal fixation device for subtalar fusion that maintains active Cannulated portions should be cleaned with a soft-bristled nylon brush, pipe cleaner, or appropriately sized guidewire. The patient should not have unrealistic expectations regarding the results that the surgery and implant may provide. The DynaNail Hybrid shares universal instrumentation with the DynaNail Mini to provide surgeons with intraoperative ease and flexibility. The DynaNail Helix Fixation System components manufactured by DJO must not be used in conjunction with screws, wire bands, or other metallic devices manufactured by any other manufacturer, as component parts may not be compatible. instruments should be fully inspected for any evidence of damage or corrosion. The DynaNail Mini Fusion System is an innovative intramedullary nail system designed for use in subtalar fusion procedures, medial column fusion procedures, and other large bone fusion procedures. Each surgeon must evaluate the appropriateness of the device and the procedure used to implant the device based on his/her own training and experience. 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