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

Model Number	KNOTLESS TENSIONABLE FIBERTAK BICEPS
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder / biceps tendon surgery the device became bent at the beginning of the surgery.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.***update dw 20-sep-2024: further information was provided that the broken fragment which was found during the investigation did not break off during the surgery.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-3687 serial/batch number (b)(6) was received for investigation.The visual evaluation revealed that the shaft was warped/bent along the shaft tip, and the notch was broken at the distal end.During the anchor system evaluation, the sutures were noted to be broken close to the anchor and tangled.Functional testing does not apply for this device.The most likely cause(s) for the reported failure can be a user error due to improper bone preparation, misaligned insertion, and/or prying/levering the device during insertion.According to dfu-0054 at revision 5.Precautions.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.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-3687 serial/batch number (b)(6) was received for investigation.The visual evaluation revealed that the shaft was warped/bent along the shaft tip, and the notch was broken at the distal end.During the anchor system evaluation, the sutures were noted to be broken close to the anchor and tangled.Functional testing does not apply for this device.The most likely cause(s) for the reported failure can be a user error due to improper bone preparation, misaligned insertion, and/or prying/levering the device during insertion.According to dfu-0054 at revision 5.Precautions.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.

• 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: 20333481
• Report Number: 1220246-2024-07900
• Device Sequence Number: 15846490
• Product Code: MBI
• UDI-Device Identifier: 00888867398757
• UDI-Public: 00888867398757
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 10/10/2024

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: 15232074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2024
• 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