MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK BUTTON; NON-DEGRADABLE FIXATN FASTENER

Model Number	FIBERTAK BUTTON
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 30-jan-2026, it was reported by a distributor via email that during a surgical procedure involving an ar-3681 fibertak button, the surgeon experienced difficulty during insertion.After placing the guide and drilling the hole, the anchor required an unusual force to advance down the inserter.A significant amount of force was then needed to mallet the anchor into the pre-drilled hole.When the surgeon attempted to convert the #2 fiberwire with the shuttling links, the shuttling sutures would not advance.The surgeon reported that the suture ultimately broke while attempting to convert it.The same drill and guide were subsequently used for a second anchor, and the second anchor was inserted without issue.This was discovered during a pec repair procedure on (b)(6) 2026.Additional information was received on 09-feb-2026: all fragments were retrieved.The case proceeded without delay, and no additional anesthesia was required.Bone quality was assessed as good, with hard bone noted.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: FIBERTAK BUTTON
• 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: 24379210
• Report Number: 1220246-2026-00657
• Device Sequence Number: 10504439
• Product Code: MBI
• UDI-Device Identifier: 00888867305458
• UDI-Public: (01)00888867305458(11)250422(17)300331(10)15424408
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K231113
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2026

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 BUTTON
• Device Catalogue Number: AR-3681
• Device Lot Number: 15424408
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2025
• 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