MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK DOUBLE LOADED FW CL; NON-DEGRADABLE FIXATN FASTENER

Model Number	FIBERTAK DOUBLE LOADED FW CL
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
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 (b)(6) 2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-3600-2 fibertak came loose.It was reported that after inserting the second fibertak anchor, a suture was passed using the suturelasso, and when pulling the nitinol with some force, the first fibertak anchor was pulled out.This was discovered during a procedure with no patient harm.The procedure was completed using a pushlock and a fiberlink to reinsert the first portion of the saturated labrum.The patient¿s bone quality was reported as good.Additional information provided 17-dec-2025: it was further reported this occurred during a shoulder arthroscopy procedure with no case delay or additional anesthesia administered.All fragments were retrieved from the patient.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation and/or misaligned insertion of the implant.

• Brand Name: FIBERTAK DOUBLE LOADED FW CL
• 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: 23887523
• Report Number: 1220246-2025-05792
• Device Sequence Number: 4668982
• Product Code: MBI
• UDI-Device Identifier: 00888867206960
• UDI-Public: (01)00888867206960(11)250929(17)300831(10)15505590
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K251809
• 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): 04/10/2026

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: FIBERTAK DOUBLE LOADED FW CL
• Device Catalogue Number: AR-3600-2
• Device Lot Number: 15505590
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2025
• 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