AP-4885 402-24-4-7915-0887 CRIMP TOOL FOR USE IN THE OPERATING ROOM

Performance Work Statement (PWS) Design and Content Introduction The VA Maine HCS requires one Dall-Miles Recon and Trauma Cable System, for the Operating Room at Togus. Background Our goal in the VA is to provide veterans the world-class benefits and services they have earned and to do so by adhering to the highest standards of compassion, commitment, excellence, professionalism, integrity, accountability, and stewardship.

The Operating Room needs a Dall-Miles Recon and Trauma Cable System as a back up to our reusable medical equipment (RME) so that we have a back up in the vent the RME is contaminated in order to not cancel surgeries in the event of a fracture during a joint surgical case. This can help the cost of a surgical joint case that could be sent to the community.

Scope (Provide an overview of the PWS emphasizing the most important aspects of your requirement and defining the boundaries of the contractor s performance responsibilities). The Dall-Miles Recon and Trauma Cable System provides the surgeon with a variety of methods for achieving trochanteric reattachment and for cerclage fixation. The Dall-Miles Grip and Grip Plate are designed to provide superior fixation for reattachment of the greater trochanter following osteotomy or fracture.

The Grip Plate provides additional distal fixation to help counteract the torsional forces of the abductor muscles. The Dall-Miles Recon and Trauma Cable System features the following features such as: Trochanteric Grips Lowprofile, 4 mm thickness. Diverging proximal hooks to capture trochanter. Sharp, distal spikes for rotational stability. Available in Small, Medium, and Large sizes in Vitallium and Stainless Steel. Trochanteric Grip Plates Malleable to fit patient s anatomy. Lowprofile, 4 mm thickness.

Diverging proximal hooks to capture trochanter. Screw hole options to augment fixation and provide rotational stability. Available in 2 proximal sizes with 3 length options each in Vitallium and Stainless Steel. Dall-Miles Cables Over 20years of clinical history. Over 100 published papers demon strating clinical success. Patented manufacturing process provides superior fatigue properties. Available in Vitallium and Stainless Steel, 1.6 mm and 2.0 mm sizes.

Item Number Item Description Qty 6704-9-150 D/M CRIMP TOOL 1 6210-0-000 HRIS HANDLE ASSEMBLY 1 6210-0-001 HRIS REPLACEMENT HANDLE SCREW 1 6704-9-320 D/M ONE-SIDED CABLE TENSIONER 2 6704-9-650 CABLE GRIP STD PASS/CANN 1 6704-9-660 ANGLED CABLE PASSER 1 6704-9-620 SUBTROCHANTERIC CABLE PASSER 1 6704-9-420 D/M FLUSH CUTTER 1 6704-9-200 CABLE GRIP INTRODUCER 1 6704-9-520 D/M SLEEVE HOLDING FORCEPS 1 6704-9-960 D/M INSTRUMENT TRAY #1 1 6704-9-970 D/M INSTRUMENT TRAY #2 1 Applicable Directives (List all documents referenced in the next section 5.0, Performance Requirements, with which the contractor will have to comply in performance of the contract effort.

If only portions of a given document apply, specifically identify the applicable portions). The system must meet the manufacturer s specifications and be designed and implemented within the vendors 510K system design as an FDA regulated medical device/system. Performance Requirements (Identify what the contractor is required to do (major tasks and subtasks). The vendor will provide the Dall-Miles Cable System as specified in the quote provided. No additional requirements for these units. Deliverables (List all data required to manage or monitor contractor performance). Vendor will provide a Standard 1-Year Warranty.