SSJ_Arthroscopy.pdf

Single Source Justification (Simplified Acquisition)

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Section A: General Contract Information

Contracting Activity: 60th Contracting Squadron

Project/Program Name: Nexus McCain Arthroscopy Systems

Purchase Request/Identification Number: FM442790980077

Estimated Contract Cost (including Options): $77,702.00

Section B: Description of the Supplies/Services Required

Arthroscopy of the temporomandibular joint (TMJ) is required in patients who have failed conservative management for TMJ arthralgia, articular disorder or osteoarthritis. It is therapeutic, aids in diagnosis, and allows for minimally invasive procedures. The addition of arthroscopy to one's practice can significantly improve the management of these patients. In order to competently perform arthroscopy of the TMJ, it is imperative that adequate equipment and instrumentation be used. This helps the surgeon properly perform an arthroscopic examination, biopsy of synovial tissue, and advanced minimally invasive operative procedures when required. Without proper equipment, there is a higher risk of complications, increased surgical time, and decreased patient outcomes.

The instrument consists of two TMJ arthroscopy scopes with two backup scopes as well as two 1.8mm and one 2.7mm arthroscopy instrument systems. This set allows two back to back cases to be completed in the OR. Scopes are connected to the camera system, which allows visualization of a small joint space onto a monitor. 1.8mm and 2.7mm instruments consist of multiple hand instruments in each set. They are specialized instruments to manipulate, debride, and obtain a biopsy of the TMJ

1.8MM MCCAIN ARTHROSCOPY SYTEM QTY: 2

1.9MM MCCAIN ARTHROSCOPY SYTEM QTY: 4

2.7MM MCCAIN ARTHROSCOPY SYTEM QTY: 1

Section C: Justification for Soliciting from a Single Source or Brand Name

There are specific features of TMJ instrumentation that are important. The Nexus TMJ arthroscopy set is the only commercially available system that meets all the following requirement for a TMJ arthroscopy. 1. Adequate length - In regards to the scope cannula, one requires a length of 45mm to access deeper joints. Pathology often lies along the medial sulcus. Shorter cannula systems would be unable to diagnose or address these issues. 2. Scoring marks - Measurements allow the surgeon to insert obturators safely to specific distances (20mm) to avoid catastrophic complications including tympanic membrane perforations, middle ear injury and intracranial entry through the glenoid fossa. 3. Interchangeability of operative cannula systems - To perform operative arthroscopic maneuvers including shavers and ablators, a larger 2.7mm cannula system is required. Switch sticks are paramount in changing to larger operative cannulas safely. The switch stick allows for the smaller 1.8mm cannula systems to be switched to a larger 2.7mm cannula system without creating additional perforations through the capsule or risking any additional iatrogenic injury to the temporomandibular joint. 4. Ergonomic design - Light cord and scope attachment, must be ergonomic, allow for rotation without impinging on external ear.

Section D: Efforts to Obtain Competition

A google search concluded that there are only two companies that fabricate TMJ arthroscopy systems: Nexus and Storz. Currently, Nexus is the only company with extensive small and large cannula systems specific to the temporomandibular joint. Storz's scope system does not meet the specific features described above. It has a short length without scoring marks. Interchangeable operative cannula system does not exist in their system. Also, the light cord comes off of the scope at 90 degrees, which severely impede the surgeon's ability to enter into the anterior recess of temporomandibular joint to make a second puncture for the operative cannula. Also, there is only a limited number of hand instruments that are compatible with their system. Please refer to the attached brochures for details.

Section E: Steps to Preclude Future Single Source or Brand Name Awards

Additional market research will continue to be accomplished in order to become aware of all sources that met similar requirements.

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Section F: Contracting Officer's Determination

I have determined, in accordance with FAR 13.106-1(b)(1), that the circumstances of this contract action deem only a single source is reasonably available.

Brand Name Urgency Exclusive Licensing Agreement Industrial Mobilization Other

Date Name and Rank/Grade of Requiring Activity Member Signature of Requiring Activity Member

Date

13-May-2019

Name and Rank/Grade of Contracting Officer

SSgt Gage V. Bergman

Signature of Contracting Officer

20 Apr 2017 Page of Section A: General Contract Information Section B: Description of the Supplies/Services Required Section C: Justification for Soliciting from a Single Source or Brand Name Section D: Efforts to Obtain Competition Section E: Steps to Preclude Future Single Source or Brand Name Awards Section F: Contracting Officer's Determination I have determined, in accordance with FAR 13.106-1(b)(1), that the circumstances of this contract action deem only a single source is reasonably available.

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