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	Insufficient Information (4580)
Date of Event	12/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: device was discarded by the facility; however, a picture was provided by the customer which was used for evaluation.A photograph of an ar-3671ds was received for evaluation.Evaluation of the photograph showed signs of damaged and melted plastic.Due to the lack of information provided and the device not being returned, a root cause cannot be confirmed.The most likely cause is use error due to leveraging the device; creating additional forces and friction within the device leading to overheating.Complaint is confirmed.
Event or Problem Description
On (b)(6) 2022 it was reported by a sales representative, via email, that while drilling with the 1.9 mm drill with the inserter from an ar-3671ds fibertak biceps disposables kit, the drill became very hot and melted the inside of the inserter and couldn't be removed further.Another fibertak biceps disposables kit was opened to complete the case.This was discovered during a distal bicep repair on (b)(6) 2022.Additional information received on 12/17/2022: nothing broke nor melted inside the patient.

• 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: 18030690
• Report Number: 1220246-2023-08442
• Device Sequence Number: 17630869
• Product Code: HTW
• UDI-Device Identifier: 00888867305410
• UDI-Public: 00888867305410
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/30/2023

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: 12273884
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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