DynaNail® TTC Fusion System - Removal Instructions

1. REMOVAL INSTRUCTIONS

2. INTRODUCTION The DynaNail® TTC Fusion System offers a simple, reliable removal approach using the Removal Tool Assembly in the event an Implant must be removed some period of time following implantation. This guide describes the steps taken to remove the DynaNail from a patient. INSTRUMENTS REQUIRED Items in DynaNail Instrument Tray: 1. 2200-12-0035 - 3.5 mm Hex Driver Shaft 2. 2200-13-0030 - 3 mm Hex Driver, T-Handle 3. 2200-11-0001 - Blue-Handle Ratchet Driver Items Available Upon Request: 4. 2200-24-0002 - Removal Tool Strike Plate Assembly 5. 2200-26-0000 - Hammer Assembly 6. 2200-24-0001 - Removal Tool Nail Connection For a complete description of the DynaNail Implant System and Instrument Tray, refer to the DynaNail Surgical Technique Guide. 3 4 1 6 5 2

3. REMOVAL TECHNIQUE 1 Remove the End Cap from the distal end of the DynaNail Implant with the 3 mm Hex Driver, T-Handle to expose the internal threads in the DynaNail’s Sliding Element (pictured below). 3

4. 2 On the back table, fully thread the Removal Tool Nail Connection onto the threaded tip of Removal Tool Strike Plate Assembly until finger tight (as depicted below in inset A). Thread the tip of the Removal Tool Nail Connection into the Sliding Element of the DynaNail Implant, advancing the threads until the Removal Tool Strike Plate Assembly is finger tight in the DynaNail (pictured below). A

5. 3 Remove the Headless PA Screw in the calcaneus and Headed Cortical Screws (one in calcaneus and anywhere from one to three in tibia) using the 3.5 mm Hex Driver Shaft and Blue-Handle Ratchet Driver (”A” in image below). 4 To remove the DynaNail Implant, pull on the Removal Tool Strike Plate Assembly by hand or with the Hammer Assembly (”B” in image below). Slide the Hammer Assembly along the shaft of the Removal Tool Strike Plate Assembly toward the Removal Tool Strike Plate Handle until the Implant is removed. A B TECH TIP: If it is difficult to unthread the DynaNail from the Removal Tool Nail Connection, utilize the holes in the Nail and Removal Tool Nail Connection to gain additional mechanical torque. 5 To release the DynaNail Implant from the Removal Tool Strike Plate Assembly, retract the Removal Tool Nail Connection by rotating it in the opposite (counter-clockwise) direction. At that point, the DynaNail can be rotated freely from the Removal Tool Strike Plate Assembly. 5

6. MedShape, as the manufacturer of this device, does not practice medicine and does not recommend this or any other surgical technique for use on a specific patient. The surgeon who performs any procedure is responsible for determining and utilizing the appropriate techniques for such procedure for each individual patient. MedShape is not responsible for selection of the appropriate surgical technique to be utilized for an individual patient. Always refer to the package insert, product label and/or product instructions prior to using any MedShape product. For further product information or to arrange a product demonstration, please contact your local MedShape representative or call Customer Service at 877-343-7016. You can also visit www.medshape.com. MedShape, Inc. 1575 Northside Drive, NW Suite 440 Atlanta, GA 30318 T: 877-343-7016 F: 877-343-7017 CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. ©MedShape, Inc., 2014. All rights reserved. Printed in the USA. Pat.: http://www.medshape.com/patents.html. MK-10121 Rev 01. Issued 01/2019. DynaNail is a registred trademark of MedShape, Inc. All other trademarks are trademarks of their respective owners and holders.