MAUDE Adverse Event Report: ARTHREX, INC. SELF-PUNCHING TRIPLE LOADED FIBERTAK; NON-DEGRADABLE FIXATN FASTENER

Model Number	SELF-PUNCHING TRIPLE LOADED FIBERTAK
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
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 06/09/2025, an arthrex subsidiary employee reported via email that (qty.2) of an ar-3641sp knotless 2.6 fibertak soft anchor and an ar-3633sp 2.6 fibertak sp soft anchor failed to remain in place and became loose.The procedure was completed using replacement anchors of the same product.This was discovered during a rotator cuff procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested on (b)(6) 2025.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.Complaint allegation is not confirmed.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 of the reported failure is user error in the device, which can be attributed to prying/leveraging, misalignment, and/or excessive force used during implant insertion.
Event or Problem Description
Additional information was received: the (qty.2) of an ar-3641sp knotless 2.6 fibertak soft anchor and an ar-3633sp 2.6 fibertak sp soft anchor were removed from the patient.There was no case delay, and no added anesthesia was administered.No adverse effects were reported on or after the surgery.

• Brand Name: SELF-PUNCHING TRIPLE LOADED 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: 22338579
• Report Number: 1220246-2025-02684
• Device Sequence Number: 8930477
• Product Code: MBI
• UDI-Device Identifier: 00888867369962
• UDI-Public: (01)00888867369962(11)241217(17)291130(10)15363108
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200341
• 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): 10/03/2025

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: SELF-PUNCHING TRIPLE LOADED FIBERTAK
• Device Catalogue Number: AR-3633SP
• Device Lot Number: 15363108
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 10/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2024
• 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