SAM #36C25627Q0122

VA market research for Shukla Medical orthopedic extraction systems or equal

The Department of Veterans Affairs is researching orthopedic extraction and removal systems for its Houston medical center. - Government buyer: Department of Veterans Affairs, Network Contracting Office 16; for the Operative Care Line at the Michael E. DeBakey VA Medical Center in Houston, Texas. Point of contact: Robert (Dustan) Arabie. - OEM: Shukla Medical is the named manufacturer; equal products may also be proposed. - Requested systems: - Trauma Maxi Extraction System — 1, part S9MAXI-TR. - Mini Small Bone Screw Removal System — 2, part S9MINI. - Broken and Stripped Screw Removal System — 1, part S9SCREW; includes 4 extractors and 2 drill bits. - Knee Extraction System — 1, part S9KNEE. - Osteotome Blade System — 2, part S9BLADE. - Hip Stem Extraction System — 1, part S9HIP. - Cervical, Thoracic, and Lumbar Spine Removal System — 1, part S9SPINE-PLUS; includes 2 instrument trays. - Shoulder Extraction System — 1, part S9SHLDR. - Flexible Shoulder Osteotome Blade System — 1, part S9SHLDR-BLADE. - Key requirements: Systems must be complete and procedure-ready, reusable, sterilizable, and FDA-compliant. Equal products must work with the facility’s existing instruments, sterilization processes, and clinical workflows. The VA seeks vendor capability information and estimated pricing; this is market research, not a solicitation.

Description

Sources Sought Notice Sources Sought Notice

Sources Sought Notice - RFI Attachment Sources Sought Notice Page 1 or 4 DISCLAIMER: THIS IS A SOURCES SOUGHT NOTICE ONLY. THIS SYNOPSIS IS NOT A REQUEST FOR QUOTE, PROPOSAL, OR BID. This notice is not a solicitation as defined by FAR 2.101, therefore it shall not be construed as a commitment by the government to enter into a contract, nor does it restrict the government to an acquisition approach. All information contained in this Request for Information (RFI) is preliminary as well as subject to amendment and is in no way binding on the government. Information submitted in response to this notice is voluntary; the government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the government. The government is requesting that restrictive or proprietary markings not be used in response to this notice. If a solicitation is released, it will be synopsized in the Federal Contract Opportunities website or General Services Administration (GSA). It is the responsibility of the interested parties to monitor these sites for additional information pertaining to this RFI. 1. Title: Shukla Universal Screw Extraction Systems (Brand Name or Equal)

1. Purpose: The Department of Veterans Affairs (VA), Network Contracting Office 16, is conducting market research to identify qualified sources capable of furnishing the brand-name items listed below or equal products for the Michael E. DeBakey VA Medical Center, Houston, Texas. This notice is issued for planning purposes only and is not a solicitation, request for quotation, invitation for bid, or promise of a future procurement. The Government will not pay for information submitted in response to this notice.

The Operative Care Line requires orthopedic extraction and removal systems used in trauma, total joint, spine, shoulder, and related surgical procedures. The current clinical need is to replace existing instrumentation while preserving safe integration with the facility s established surgical workflows and currently owned Shukla Medical sets.

Item Brand-Name Reference Description Qty/Unit 1 S9MAXI-TR Extraction System, Trauma Maxi 1 EA 2 S9MINI Removal System, Screw, Mini, Small Bone Screw V4 2 EA 3 S9SCREW Removal System, Screw, Broken & Stripped V3; extractors, 4 each; drill bits, 2 each 1 EA 4 S9KNEE Extraction System, Knee 1 EA 5 S9BLADE Blade System, Osteotome 2 EA 6 S9HIP Extraction System, Hip Stem 1 EA 7 S9SPINE-PLUS Removal System, Spine, Cervical, Thoracic, and Lumbar; includes two instrument trays V4 1 EA 8 S9SHLDR Extraction System, Shoulder 1 EA 9 S9SHLDR-BLADE Blade System, Shoulder, Flexible Osteotome 1 EA

1. Minimum Salient Characteristics for Equal Products: Provide complete, procedure-ready systems that perform the same clinical function as each corresponding brand-name reference item. Include the specialized drivers, extractors, drill bits, osteotomes, handles, adapters, and organization/sterilization trays ordinarily required for the identified system s intended surgical use. Be designed for precision removal and, where applicable, insertion of orthopedic hardware, including large bone screws and broken or stripped screws. For the spine system, support cervical, thoracic, and lumbar applications and include two instrument trays. For shoulder and osteotome systems, provide instrumentation suitable for the stated shoulder extraction or flexible osteotome function. Be compatible with the medical center s existing instruments, trays, sterilization processes, and clinical workflow without requiring undocumented adapters, modifications, or additional capital equipment. The respondent shall identify any exceptions or additional items required for full functionality. Be reusable surgical-grade instrumentation and capable of cleaning, disinfection, and steam sterilization consistent with VA facility practices. Provide the manufacturer s validated reprocessing and sterilization instructions. Be supplied new, not used or refurbished, with product labeling, instructions for use, and applicable warranty and support information. Be commercially available and compliant with all applicable FDA requirements for the offered intended use. Respondents shall identify the applicable clearance, listing, registration, or exemption status.

The Small Business Administration (SBA) size standard for the North American Industry Classification System (NAICS) code is 339113 Surgical Appliance and Supplies Manufacturing with a size standard of 800 employees. Product Supply Code (PSC) 6515 Medical and Surgical Instruments, Equipment, and Supplies.

The anticipated type of contract shall be a Single Award, Firm Fixed Price.

1. Responses Requested: The following questions must be answered in response to this RFI. Answers that are not provided shall be considered non-responsive to the RFI: Name of potential Contractor that possess the capability to fulfill this requirement. Contractors shall also provide the following:

Point(s) of contact name: _______________________________________________

Address: ____________________________________________________

Telephone number: ___________________________________________

Email address: _______________________________________________ UEI #: ____________________________________

CAGE Code: _______________________________

Is your company considered a small business concern, SB, SDVOSB, VOSB, HUBZone, or 8A concern, with the requisite NAICS code identified above? Can your company provide training as outlined in the attached SOW? Is your company available under any Government Wide Agency Contract (GWAC), Solutions for Enterprise-Wide Procurement (SEWP), National Acquisition Center (NAC), GSA Schedule, Federal Supply Schedule (FSS), Indefinite Delivery Indefinite Quantity (IDIQ), and/or Blanket Purchase Agreement (BPA)?

The VA does not accept grey market items; therefore, the Vendor must attach an Authorized Distribution Letter as an approved and authorized vendor on OEM letterhead by the manufacturer as evidence of proof to be viewed by the government to be considered as part of the Market Research and responsiveness to this Sources Sought notice.

1. Opportunity/Market Pricing: The MEDVAMC is seeking information from potential vendors on their ability to provide the required items/equipment. THIS IS A SOURCES SOUGHT REQUEST FOR INFORMATION (RFI) ONLY. Small Business concerns are encouraged to provide responses to this RFI in order to assist the MEDVAMC in determining potential levels of competition and general market pricing available in the industry. Vendors are requested to submit estimated market research pricing along with their responses to the above. The estimated pricing will be considered when determining the procurement strategy for the forthcoming solicitation.

2. RFI responses are due by 3:00pm Central Time by close date listed above

The subject line shall reference that Request for Information (RFI) number above.

NO SOLICITATION EXISTS AT THIS TIME.

Please provide the information you deem relevant in order to respond to the specific inquiries of the RFI.

Information provided will be used solely by MEDVAMC as Market Research and will not be released outside of the MEDVAMC Purchasing and Contracting Team.

If no responses to this notice are received from an authorized distributor of the cited brand name items listed above, then this action will be sole sourced to the manufacturer.

1. Contact Information: Contract Specialist Robert (Dustan) Arabie robert.arabie@va.gov

Your response to this notice is greatly appreciated!

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