MAUDE Adverse Event Report: ARTHREX, INC. DX FIBERTAK SUTURE ANCHOR, #1 FW & NDLS; NON-DEGRADABLE FIXATN FASTENER

Model Number	DX FIBERTAK SUTURE ANCHOR, #1 FW & NDLS
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
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, an arthrex subsidiary employee reported via email that an ar-8990ds disposables kit for fibertak dx suture anchor and an ar-8990 fibertak dx suture anchor were involved in an issue during surgery.The surgeon requested the fibertak anchor and proceeded with the standard technique, inserting the drill bit and then hammering the anchor.During insertion, the anchor tip bent.An attempt was made to correct the tip for continued use, but the same issue occurred; the tip bent again.The patient¿s bone quality was assessed as good, and no additional anesthesia was administered.This was discovered during a procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on 12/02/2025: this occurred during a reconstruction of the tendon of the second toe procedure.The anchor bent twice during initial insertion.The tip was corrected using a kelly instrument.The bent anchor was removed and not implanted.The procedure was completed without surgical delay.The drill bit from the kit was used for preparing the bone.No photos were taken, and no adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information available, including the returned device (if applicable), photographs, event description, and field feedback, arthrex has determined the most likely cause is attributed to off-axis loading or the use of excessive force during malleting, which can prevent the implant from seating properly and lead to mechanical disengagement or failure during insertion.

• Brand Name: DX FIBERTAK SUTURE ANCHOR, #1 FW & 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: 23815205
• Report Number: 1220246-2025-05617
• Device Sequence Number: 9386669
• Product Code: MBI
• UDI-Device Identifier: 00888867265004
• UDI-Public: (01)00888867265004(11)250327(17)300228(10)15410734
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 03/24/2026

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, #1 FW & NDLS
• Device Catalogue Number: AR-8990
• Device Lot Number: 15410734
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2025
• 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