MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK BICEPS INSTRUMENT SET; DRILL BIT

Model Number	FIBERTAK BICEPS INSTRUMENT SET
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a biceps tenodesis surgery the metal sleeve rotated in the blue plastic, causing heat development and the plastic melted.There was no harm for patient, operator or third party.The surgery was finished successfully with a different device, ar-1923bc-1 and the threads of the fibertak were inserted with a pushlock.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-3671ds serial/batch number (b)(6) was received for evaluation.Visual inspection found that the 1.9 mm.Drill was stuck inside the fibertak drill guide handle due to the melted material of the handle.It was observed damaged on the outside diameter close to the slot of the shaft.User error is the most likely cause for the reported and observed failure.Caused by prying/leveraging of the device against bone/bony tissue, use of the device for extended periods, and/or excessive activation time of the device can cause it to overheat.

• Brand Name: FIBERTAK BICEPS INSTRUMENT SET
• Common Device Name: DRILL BIT
• 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: emily shafer ; 8009337001
• MDR Report Key: 18367478
• Report Number: 1220246-2023-09523
• Device Sequence Number: 7912788
• Product Code: HTW
• UDI-Device Identifier: 00888867305410
• UDI-Public: 00888867305410
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: EXEMPT
• 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): 06/12/2024

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: FIBERTAK BICEPS INSTRUMENT SET
• Device Catalogue Number: AR-3671DS
• Device Lot Number: 14774519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2023
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2021
• 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