MAUDE Adverse Event Report: ARTHREX, INC. DX FIBERTAK SUTURE ANCHOR, #2 MTS W/ NDL; NON-DEGRADABLE FIXATN FASTENER

Model Number	DX FIBERTAK SUTURE ANCHOR, #2 MTS W/ NDL
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 06-feb-2026, a sales representative reported via email that three ar-8991 fibertak dx suture anchors did not maintain tension throughout the range of motion.The issue was identified during a procedure on (b)(6) 2026.No patient harm was reported.Additional information was received on 12-feb-2026: this occurred during a lateral epicondylitis (tennis elbow) procedure.After experiencing three malfunctions, they converted to a different knotted anchor and successfully completed the case using an ar-8990st-2 fibertak dx suture anchor, double-loaded.The procedure was delayed by approximately ten minutes, and no additional anesthesia was administered.

• Brand Name: DX FIBERTAK SUTURE ANCHOR, #2 MTS W/ NDL
• 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: 24430518
• Report Number: 1220246-2026-00895
• Device Sequence Number: 10304063
• Product Code: MBI
• UDI-Device Identifier: 00888867377295
• UDI-Public: (01)00888867377295(11)250429(17)300331(10)15428166
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K200341
• 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): 05/21/2026

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, #2 MTS W/ NDL
• Device Catalogue Number: AR-8991
• Device Lot Number: 15428166
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2025
• 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