MAUDE Adverse Event Report: ARTHREX, INC. 2.6 MM KNOTLESS FIBERTAK ANCHOR; NON-DEGRADABLE FIXATN FASTENER

Model Number	2.6 MM KNOTLESS FIBERTAK ANCHOR
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 11-mar-2026, a sales representative reported via email that four ar-3641, 2.6 mm knotless fibertak anchors had issues, with one of the sutures ripped, affecting either the shuttle link or the blue repair suture.This issue was discovered during a procedure performed on (b)(6) 2026.No further information was provided.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
The complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is a possible combination of the sutures being pulled in close proximity to rough bone, the application of a pull that was not slow and steady as recommended, and/or damage to the suture during the tensioning process.According to the surgical technique, a slow and steady pull is recommended to allow the anchor to properly deploy.A fast or aggressive pull may result in improper anchor setting.The technique further instructs applying a slow, consistent pull on the suture limbs until sufficient tension is achieved, allowing tension to be controlled and adjusted under direct visualization.Note: before converting the knotless mechanisms, ensure the 2-0 fiberlink shutting suture is free of twists.Directions for use dfu-0054 at revision 8 bio-fastak, fastak¿, suturetak® and fibertak® suture anchors.G.Precautions.Insert the anchor with the same orientation as that of the prepared drilled bone hole to avoid damage to the anchor or inserter.Suturetak and fibertak suture anchors only: anchors loaded on flexible drivers: the drill guide tip must remain in contact with the bone surface during the drilling and implant impaction steps of the procedure.Failure to do so may result in difficulty seating the implant to its intended depth.Avoid excessive impaction during anchor insertion as this could lead to inserter damage and/or breakage.If insertion resistance is encountered, do not impact harder.Replace the implant and repeat the drilling/insertion process.Arthrex implant specific instrumentation must be used to insert implantable devices per the recommended surgical technique.The complaint allegation was not confirmed.No evidence of that failure was received.
Event or Problem Description
Additional information was received on 17-mar-2026: this issue occurred in the patient during a rotator cuff repair procedure.The suture broke on one of the anchors at the repair suture, and on the other anchors, the shuttle suture tore.All broken suture fragments were retrieved, and the affected anchor was removed.The procedure was completed using a different device, an ar-3652tsp fibertak rc suture anchor.The case was not delayed, and no additional anesthesia was required.

• Brand Name: 2.6 MM KNOTLESS FIBERTAK ANCHOR
• 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: 24642034
• Report Number: 1220246-2026-01538
• Device Sequence Number: 13241390
• Product Code: MBI
• UDI-Device Identifier: 00888867287457
• UDI-Public: (01)00888867287457(11)240415(17)290331(10)15234333
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K251809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2026

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: 2.6 MM KNOTLESS FIBERTAK ANCHOR
• Device Catalogue Number: AR-3641
• Device Lot Number: 15234333
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/11/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown