Redacted SSJ.pdf

Single Source Justification (Simplified Acquisition)

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Section A: General Contract Information

Contracting Activity: 60th Contracting Squadron

Project/Program Name: Tornier shoulder arthroplasty system

Purchase Request/Identification Number:

Estimated Contract Cost (including Options):

Section B: Description of the Supplies/Services Required

Total shoulder arthroplasty is indicated in patients with proximal humerus fracture and/or who have failed conservative management for disorders of the glenohumeral joint including osteoarthritis, post-traumatic arthritis and rotator cuff arthropathy. Variations in patient anatomy, including acquired deformities of the articular surfaces, are common in shoulder replacement surgery. Failure to recognize and account for these differences can lead to inferior clinical outcomes. The Tornier total shoulder system includes a 3D modeling software which allows for a more thorough pre-operative analysis of each patient's inherent anatomy. From the software system, patient-specific instrumentation can be generated to account for anatomic variations. The Tornier total shoulder implant system includes augmented components which allow for correction of deformities of the articular surfaces. Using augmented components helps the surgeon to restore normal anatomy and improve biomechanical properties of the artificial joint. Lastly, the Tornier system offers the option of using a modular stem that incoporates a cementless fixation option specific for fractures.

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

Patient is a diabetic with osteoporosis and has a displaced proximal humerus fracture in need of urgent surgery. Tornier is the only shoulder arthroplasty system which incorporates 3D pre-operative planning, patient-specific instrumentation, augmented components on both primary and reverse shoulder arthroplasties and a modular stem with a cementless fixation option for fractures. Dr. Skordas has used this system exclusively during his fellowship and for all of the total shoulder arthroplasties he has performed in the past two years at David Grant Medical Center.

Additionally, we are requesting urgent approval of this justification by 19 June 2020 in order to perform the patient's surgery on 22 June 2020. Any delay of her surgery past that date would subject the patient to unnecessary pain and suffering. Additionally, any delay in surgery for this type of fracture, significantly increases the risk of surgical complications and poor outcomes.

Section D: Efforts to Obtain Competition

There are currently three other total shoulder systems on ECAT (Stryker, DePuy and Zimmer). Stryker and DePuy do not offer augmented components or a cementless fracture stem. Zimmer only offers patient-specific instrumentation and augmented components on their reverse shoulder system.

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 meet similar requirements.

Single Source Justification (Simplified Acquisition)

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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