Stryker Surgical Drill LSJ 12.3.25_Redacted.pdf

System 8 Stryker handpieces (discontinued, but being replaced by and compatible with system 9 items)( 4505-000-000).

The current orthopedic marketplace consists of orthopedic implant manufacturers that produce their own line of orthopedic products. Unlike many other industries, product selection in the orthopedic implant industry is not based solely on price and is overshadowed by physician preference/experience and highly specialized training on use of specific surgical items. A physician’s decision to use a particular manufacturer’s product is based on the technical characteristics of the products that are expected to produce a higher quality of life for their patients or achieve certain surgical results. Stryker products and the surgical procedures used are unique and proprietary, as is the industry standard, and require highly specialized training on the part of the physician. Once trained and comfortable with a particular manufacturer’s products and the surgical procedure, the physician will likely use that manufacturer’s products for the duration of their career.

All surgical instruments, components, drill bits, saws, etc. are sent to SPS (Sterile Processing Service) for decontamination, cleaning, and re-sterilization. They are placed on trays and sterilized. SPS does not segregate different manufacturers equipment to separate groups during this process. Therefore, during this process, if there are both Stryker equipment and components (already in current use in the OR) and another vendor’s drills and components in the sterilization process, mixing of components will occur. This will result in a high probability that components from one manufacturer being mixed with the alternate manufacturer and put into the sterile pack.

When the sterile pack is delivered to the OR and placed in the surgical suite, and it is found that there is a mix up between the drill and the components, it results in either complete cancellation of the surgery or significant delay in the surgery. If the case is delayed, this will cause the patient to be under anesthesia for longer than they should be, and this could result in adverse outcomes during recovery, up to and including patient death. Stryker has full FDA 510K clearance, but only for Stryker branded drills, chargers, surgical saws, etc. To use alternate vendor components on Stryker drills, or to place Stryker components into a non-Stryker drill voids the FDA 510K clearance, resulting in their exemption from liability and full liability is placed on Eglin AFB.

All products used must have FDA 510k clearance and since mixing components voids that clearance it simply cannot be done.

No other manufacturer has the capability of meeting Eglin AFB requirements listed above. Only the Stryker items are capable of satisfying the requirements.

5. DLA Troop Support has already determined the prices of the supplies under the ECAT Multiple Award Schedule Program fair and reasonable based on a favorable comparison to other than certified cost or pricing data. Request for Quotation (RFQ) will be sent to all Medical/Surgical contract holders prior to placement of the delivery order in an effort to obtain