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

Model Number	KNOTLESS TENSIONABLE FIBERTAK BICEPS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a biceps tenodesis surgery the device broke.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-3687 batch 15302079 was received for evaluation.Visual inspection found that the device arrived without the anchors/sutures for evaluation.The notch was broken off.Functional testing was not performed as the device was received broken/damaged.The method of bone preparation employed during the procedure and the bone quality encountered were not provided.The most likely cause of the reported failure is user error, specifically excessive impaction, which could result in damage to the inserter and/or breakage.

• 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: 22687746
• Report Number: 1220246-2025-03204
• Device Sequence Number: 9473271
• Product Code: MBI
• UDI-Device Identifier: 00888867398757
• UDI-Public: (01)00888867398757(11)240814(17)290731(10)15302079
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K222161
• 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,Followup
• Report Date (Section B): 08/18/2025

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: KNOTLESS TENSIONABLE FIBERTAK BICEPS
• Device Catalogue Number: AR-3687
• Device Lot Number: 15302079
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/14/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown