Matrixmandible Set

LIMITED SOURCE JUSTIFICATION - 1. Defense Logistics Agency (DLA) Troop Support, Medical Supply Chain, Electronic Catalog (ECAT) Division, is the contracting activity. - 2. The justification is for the acquisition of Synthes CMF Matrixmandible Implant and Instrument Set. This order will be placed against all responsive ECAT vendor catalogs or responsible Government vendors. One known ECAT vendor, Beacon Point Associates, contract SPE2DE-15-D0012, which expires February 11, 2020 will be contacted for a best and final quote along with those from any competitive ECAT vendor. - 3. Naval Medical Center Camp Lejeune, NC has the following requirement for Matrix Mandible Implant and Instrument set which will allow more Oral Maxillofacial surgeries for patient care. Item: Synthes Matrix Mandible Implant & Instrument Set Part Number: 6515016447977 National Stock Number (NSN): NA Quantity: 1 Each - 4. This action is being conducted under the Multiple Award Schedule Program. The authority waiving the competition requirement is FAR 8.405-6 (b)(1), DFARS 208.405-1, Order Placement - only one manufacturing source meets the capability of providing the supplies or services required under FAR l 6.505(b)(2)(ii). The supplies or services ordered are highly specialized and unique to Synthes. - 5. At NMCCL, the Main Operating Room has additional Oral Maxillofacial surgeons doing a variety of surgical procedures which with the purchase of these instrument set will give us the capability to do more mandible/trauma cases so that they are not referred out to the network. The minimum clinical performance requirements: All screws work with all plates in the system Reduced plate/screw profile Improved screw retention and reduced cam out Standardized instrumentation Reduced inventory for hospitals without compromising clinical solutions Comprehensive anatomical locking plates Flexibility in selecting the best screw plate combination Simplified instrumentation Color coding for correct Implant and instrument selection Screw angulation up to 15 degrees Conical locking technology for screw-plate security Multiple plate thicknesses Rounded plate profiles and edges Improved angle plate designs reduces stress in critical areas Larger reconstruction plates available for bridging Longer ramus section on reconstruction plates Preformed curved Mandible plates Plates show a reduced stress in transition areas - All components of the approved 6515-01-644-7977 NSN. - All components are manually operated and do not require an electrical power source. - Food and Drug Administration certification. - 6. DLA has determined the price of the mandible plating set to be fair and reasonable based upon price analysis of the product submission of the ECAT vendor. This acquisition represents the best value to the Government consistent with FAR 8.404(d) and will result in the lowest overall cost alternative to meet the Government's needs. 7. Market research was completed by Sterile Processing Supervisor at NMCCL, D. Lynn Bowden Williamson. KLS Martin and Stryker instrument sets were also researched by various google searches and vendor onsite visits and were ruled out based on limited compatibility to work with existing systems when compared to Synthes. Synthes Matrix Mandible Implant and Instrument was thoroughly examined for details by Oral Maxillofacial surgeons and it was determined that this instrument set will best meet the needs at NMCCL. The Medical Master Catalog was utilized to determine that requested item is on ECAT.