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

Model Number	FIBERTAK BUTTON
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a distributor reported via email that an ar-3681 fibertak button malfunctioned during use.The surgeon placed three anchors, and upon setting the third anchor, the anchor would not bunch/set.The anchor pulled from the bone, they attempted to reset it on the inserter and try again, but the same thing happened.After inspecting the back table, the anchor would not bunch when all suture limbs were pulled.They opted to open a new anchor, and it worked without issues to complete the case.This was discovered during a pec repair procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on 06/23/2025: the case was delayed 15 minutes.It is uncertain if added anesthesia was administered.No adverse effects were reported on or after the surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: 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.

• 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: 22397068
• Report Number: 1220246-2025-02729
• Device Sequence Number: 4825615
• Product Code: MBI
• UDI-Device Identifier: 00888867305458
• UDI-Public: (01)00888867305458(11)230404(17)280331(10)15076527
• 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): 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: FIBERTAK BUTTON
• Device Catalogue Number: AR-3681
• Device Lot Number: 15076527
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/09/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 10/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown