Brand Name Justification AP3847 (Stryker Core)_Redacted.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

Last Updated: 02/01/22 Page 1 of 3

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

1. Contracting Activity: Ordering Activity:

Department of Veterans Affairs Department of Veterans Affairs Network Contracting Office 19 Oklahoma City VAMC 6162 S Willow Dr. Suite 300 921 N.E. 13th St Greenwood Village, CO 80111 Oklahoma City, OK 73104

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

The Oklahoma City VA Healthcare System (OKC VAHS), Oklahoma City campus, is requesting to purchase two (2) Stryker CORE power console systems, with two (2)TPX Elite cutting attachments, which are complete systems for various orthopedic, dental, ENT, neuro and endoscopic applications and procedures.

The Stryker Consolidated Operating Room Equipment (CORE) 2 Console is intended for use in the cutting, drilling, reaming, decorticating, shaping, and smoothing of bone, bone cement and teeth in a variety of surgical procedures, including but not limited to orthopedic, dental, ENT (Ear, Nose, Throat), neuro, spine, and endoscopic applications. The console is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices.

The Elite and Heavy Duty Attachments are intended to be used with the Stryker Consolidated Operating Room Equipment (CORETM) console and electric and pneumatic motors. When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are intended to cut bone and bone cement in the following manner: drilling, reaming, decorticating, shaping, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose and Throat (ENT)/Otology/Neurotology/Otorhinolaryngology; Craniofacial and Maxillofacial; Dental;

and Endoscopic applications. The specific applications include Craniotomy/Craniectomy, Laminotomy/Laminectomy, Minimally Invasive Surgery (MIS) Spine, Expanded Endonasal Approach (EEA)/Anterior Skull Base/Endoscopic/Transnasal/Transphenoidal, and Orthopedic Spine.When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are intended to cut teeth in the following manner: sectioning, segmenting, splitting, fragmenting, extracting, removing, drilling, and reaming. When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices, or the cutting of screws, metal, wires, pins, and other fixation devices in the following manner: sectioning, deburring, smoothing or shaping of metal, and removing/rounding sharp edges.

This requirement shall be awarded as a new contract. The contract shall be awarded as a Supply contract through NCO 19’s Supply 1 team

Last Updated: 02/01/22 Page 2 of 3

Product Description MODEL Quantity Unit CORE 2 - United States 5400-052-000US 2 each Pi Drive 2 Plus Motor 5407-350-000 2 each Elite 12cm Straight Attachment 5407-120-470 2 each Elite 12cm Angled Attachment 5407-120-472 2 each Elite 14cm Straight Attachment 5407-120-480 2 each HD 14cm Straight Attachment 5407-120-070 2 each Footed Attachment 16mm 5407-FA2-000 2 each Non Footed Attachment 8cm 5407-NFA-8CM 2 each Footed Attachment 25mm 5407-FA3-000 2 each Non Footed Attachment 9cm 5407-NFA-9CM 2 each Footswitch 5100-008-000 2 each CORE Footswtich 5402-007-000 2 each

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

The OKC VAHS has already purchased multiple Stryker Core units for use in their operating rooms.

In a phone call with Drew Tonseth, Associate Sales Representative at Stryker Neurosurgical, on 7/27/2023 at 10:05 a.m. it was conveyed that Stryker is the only company available that offers such a highly specialized comprehensive operating room system. Stryker solely owns all proprietary rights in and to the CORE and TPX Elite systems. Per Mr. Tonseth, the Stryker TPX Elite systems that are currently in use at the OKC VAHS is only compatible with Stryker devices. Therefore only the Stryker Core units are compatible with the system currently in use at the OKC VAHS. The TPX system is a tool system that is powered by the CORE console and by having the same consoles in all emergency rooms it allows surgeons to be able to use the same system in every surgery allowing for mor successful surgeries. Stryker is also the sole source manufacturer of the CORE system and all its associated instrumentation. It was also conveyed that no other vendor’s equipment will work with Stryker equipment as it is all proprietary to Stryker. Per Stryker, the VA currently has Stryker maintenance contracts for that this equipment can be added to. Market research shows that if another manufacturer’s conole were to be purchased it would cost an estimated per surgical room for the entire system and one set of tools.

4. Description of market research conducted and results or statement why it was not conducted:

Stryker was contacted to verify if there were any authorized distributors for these items. TrillaMed and Beacon Point Associates were both verified as being authorized distributors. Both companies are SDVOSB vendors. A search on VIP, SAM, GSA, NAC contracts, and SAC contracts was also conducted as well as searching FPDS for previous purchases.

5. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

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Oklahome City VA Medical Center

6. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.