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

Model Number FIBERTAK BICEPS INSTRUMENT SET

Device Problem Melted (1385)

Patient Problem Insufficient Information (4580)

Event Date 12/06/2022

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 326863510
• Report Number: 1220246-2023-08442
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 00888867305410
• UDI-Public: 00888867305410
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FIBERTAK BICEPS INSTRUMENT SET
• Device Catalogue Number: AR-3671DS
• Device Lot Number: 12273884
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1