MAUDE Adverse Event Report: Arthrex, Inc. Knotless Tensionable FiberTak Biceps Kit; NON-DEGRADABLE FIXATN FASTENER

Model Number	Knotless Tensionable FiberTak Biceps Kit
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the bicep's surgery, it was almost impossible to insert the anchor through the drill sleeve after drilling.A hammer was needed to put it though the sleeve and into the bone.The first fibertak bent completely.The second fibertak was put into the bone, but the sutures were damaged so that sliding mechanism did not work anymore.At the end they had to tie knots with the remaining sutures.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: Knotless Tensionable FiberTak Biceps Kit
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50777879
• Report Number: 1220246-2026-04741
• Device Sequence Number: 16140908
• Product Code: MBI
• UDI-Device Identifier: 00888867398740
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K251809
• 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
• Report Date (Section B): 09/15/2026

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 Kit
• Device Catalogue Number: AR-3688
• Device Lot Number: 15410612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2025
• 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