MAUDE Adverse Event Report: ARTHREX, INC. DX FIBERTAK SUTURE ANCHOR, ST & NDLS; NON-DEGRADABLE FIXATN FASTENER

Model Number	DX FIBERTAK SUTURE ANCHOR, ST & NDLS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/30/2026
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 02-feb-2026, an arthrex subsidiary employee reported via email that the tip of an ar-8990st fibertak dx suture anchor broke during insertion into the bone.The broken fragment was retrieved without issue.The event occurred during a procedure on (b)(6) 2026.There was no significant case delay, no additional anesthesia administered, and no patient harm reported.Additional information was received on 05-feb-2026: the previously reported issue involving a broken anchor was not applicable to this event.In this case, the damage occurred solely to the inserter tip during surgery, not the ar-8990st fibertak dx suture anchor itself.The anchor remained fully intact, with no impact on the strength or integrity of the fixation.As a result, the originally selected ar-8990st fibertak dx suture anchor was successfully implanted, completing the procedure without further issues.

• Brand Name: DX FIBERTAK SUTURE ANCHOR, ST & NDLS
• 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: 24381021
• Report Number: 1220246-2026-00661
• Device Sequence Number: 10518560
• Product Code: MBI
• UDI-Device Identifier: 00888867301054
• UDI-Public: (01)00888867301054(11)250721(17)300630(10)15469848
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172612
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

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: DX FIBERTAK SUTURE ANCHOR, ST & NDLS
• Device Catalogue Number: AR-8990ST
• Device Lot Number: 15469848
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2025
• 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