DynaNail® TTC Fusion System - Instructions For Use | MedShape DynaNail® TTC Fusion System - Instructions For Us | Page 8

If any of the components are damaged during aZempted placement, addi@onal sterile components of the same size should be available. Alternate fixa@on methods should also be available for use in the event that the DynaNail TTC Fusion System cannot be successfully implanted. Handling of the DynaNail Deployment Frame and the Ancillary Surgical Instruments must be performed in accordance with asep@c handling prac@ces to maintain sterility following steriliza@on by the healthcare facility. 10. REQUIRED ITEMS Ancillary Surgical Instruments are required to complete the implant procedure and to remove the DynaNail TTC Fusion Nail, DynaNail End Cap, and/or DynaNail Screws following implanta@on, if required. Intraopera@ve fluoroscopy (C-Arm) should be available and u@lized as required to confirm correct posi@oning of implantable DynaNail TTC Fusion System components. 11. DIRECTIONS FOR USE General Technique: 1. Insert the DynaNail Implant into a pre-drilled plantar hole through the calcaneus, talus and into the medullary canal of the @bia. 2. With the numbered Compression Wheel set to “0”, fully stretch the Compressive Element by pulling down on the lever. Use the Compression Wheel to dial-in the desired amount of compression (1-6), depending upon surgeon preference. Once compression has been set, release the lever back up. 3. Using the Posterior-Anterior Targe@ng Arm with the Deployment Frame 1 , drill a posterior-to-anterior hole into the calcaneus through the distal calcaneal hole in the DynaNail Implant and insert a 5mm Headless PA Screw. 4. Drill a lateral-to-medial hole into the calcaneus through the proximal calcaneal hole in across the DynaNail implant and insert a 5mm Headed Cor@cal Screw 1 . 5. Place a temporary compression drill through the distal @bial oblong slot in the DynaNail Implant 1 . 6. Turn the Manual Compression Knob on the Deployment Frame to apply external manual compression. 7. Drill a hole in at least one of the proximal @bial holes across the DynaNail Implant and insert a 5mm Headed Cor@cal Screw 1 . 8. Remove the temporary compression drill and insert a 5mm Cor@cal Headed Screw.