MAUDE Adverse Event Report: ARTHREX, INC. 2.6 DL KNOTLESS FIBERTAK; NON-DEGRADABLE FIXATN FASTENER

Model Number	2.6 DL KNOTLESS FIBERTAK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/01/2025
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 12/01/2025, it was reported by a sales representative via (b)(4) that an ar-3642sp 2.6 dl knotless fibertak was faulty.After passing the first repair stitch and retrieving the working portal with scorpion, the suture broke off from the anchor at the base (not at the end by scorpion).This was discovered during the case with no patient harm.Additional information was provided by the rep on 12/4/25.This was discovered during a rotator cuff repair of supraspinatus.No instrument was used to prepare the bone socket.Reported bone quality was good.The blue repair suture broke but it was retrieved in one piece.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is user error, including excessive force applied to the suture strands and/or improper surgical technique associated with the device.The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: 2.6 DL KNOTLESS FIBERTAK
• 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: 23865074
• Report Number: 1220246-2025-05759
• Device Sequence Number: 4437964
• Product Code: MBI
• UDI-Device Identifier: 00888867426429
• UDI-Public: 00888867426429
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K251809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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: 2.6 DL KNOTLESS FIBERTAK
• Device Catalogue Number: AR-3642SP
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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