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

Model Number	KNOTLESS TENSIONABLE FIBERTAK BICEPS
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
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 user error, resulting from one or more of the following factors: improper bone preparation, excessive impaction, misaligned insertion, and/or prying or levering during use, which led to the device damage.Directions for use dfu-0054-eo revision 7 bio-fastak, fastak¿, suturetak® and fibertak® suture anchors e.Warnings 7.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.9.Suturetak and fibertak suture anchors only: drilling in very hard bone may require cycling the drill while maintaining consistent alignment of the drill guide.Increased size, hard bone drills are also available for use.G.Precautions 4.Fastak and fibertak suture anchors only: it is important to stop drilling as soon as the chuck contacts the guide or grasper.Failure to do so may result in damage to the suture and/or implant.5.Insert the anchor with the same orientation as that of the prepared drilled bone hole to avoid damage to the anchor or inserter.6.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.7.Arthrex implant-specific instrumentation must be used to insert implantable devices per the recommended surgical technique.The complaint allegation was confirmed upon reviewing the customer¿s attached picture, which showed the tip of an inserter from a reported ar-3687 knotless fibertak® biceps, ve5, broken and bent at the distal end.
Event or Problem Description
It was reported that during the subpectoral biceps tenodesis, the tips of the inserter broke off.These remained in the patient.Prior to this, the inserter had bent several times at the tip.The surgery was finished successfully with the same device was used anyway.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: KNOTLESS TENSIONABLE FIBERTAK BICEPS
• 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: 24698658
• Report Number: 1220246-2026-01665
• Device Sequence Number: 10176906
• Product Code: MBI
• UDI-Device Identifier: 00888867398757
• UDI-Public: (01)00888867398757(11)250603(17)300531(10)15446048
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K251809
• 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
• Report Date (Section B): 03/26/2026

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: KNOTLESS TENSIONABLE FIBERTAK BICEPS
• Device Catalogue Number: AR-3687
• Device Lot Number: 15446048
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2025
• 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