MAUDE Adverse Event Report: ARTHREX, INC. PROXIMAL TENODESIS BUTTON REV: 0; NON-DEGRADABLE FIXATN FASTENER

Model Number	PROXIMAL TENODESIS BUTTON REV: 0
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 11/21/2025, a distributor reported via email that an ar-2291 proximal tenodesis button experienced an issue during use.The plastic protective piece that normally sits over the top of the button was not attached to the button and was found loose in the packaging.As a result, the peg that secures the button was weakened, and the button snapped when the user attempted to thread the fiberwire through.This was discovered during a biceps tenodesis procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on 11/26/2025: during a biceps tenodesis procedure, two ar-2291 proximal tenodesis buttons from the same lot were opened.Upon opening the packaging, staff observed that the plastic protective pieces were not attached to the buttons and were loose within the packaging.After threading fiberwire through the first button, it snapped off immediately.The procedure was completed using a second ar-2291 proximal tenodesis button, which also lacked the protective piece; however, the surgeon successfully implanted it with extra caution, and the button did not snap.The delay was approximately five minutes to open the ar-2291 replacement.Bone quality was reported as normal, and a drill pin for the biceps button was used to prepare the bone socket.Additional anesthesia administration was not confirmed.No adverse effects were reported.Following the case, staff inspected another ar-2291 proximal tenodesis button from the same lot and noted that its plastic protective piece was also not attached to the button.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Visual inspection through the sealed pouch confirms that the sterigard tip protector is missing from the distal end of the shaft, over the button end.The sterigard tip protector was loose in the packaging and was found around the handle.This is a manufacturing issue addressed through a nonconformance.

• Brand Name: PROXIMAL TENODESIS BUTTON REV: 0
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 23759250
• Report Number: 1220246-2025-05524
• Device Sequence Number: 15936089
• Product Code: MBI
• UDI-Device Identifier: 00888867026704
• UDI-Public: (01)00888867026704(11)250612(17)300531(10)15450669
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PROXIMAL TENODESIS BUTTON REV: 0
• Device Catalogue Number: AR-2291
• Device Lot Number: 15450669
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown