MAUDE Adverse Event Report: ARTHREX, INC. IMPLANT SYSTEM, FIBERTAK BUTTON; NON-DEGRADABLE FIXATN FASTENER

Model Number IMPLANT SYSTEM, FIBERTAK BUTTON

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/01/2024

Event Type  malfunction  

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 Description

On 03/05/2024, it was reported by a facility representative via e-mail that an ar-3680 fibertak® button implant systems small tip of the drill guide broke.This occurred during a posterosuperior labrum repair on (b)(6) 2024 when the device was removed from the patients shoulder another piece broke off.No additional information was provided, and additional information has been asked.

• Brand Name: IMPLANT SYSTEM, FIBERTAK BUTTON
• Type of Device: 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: 18959335
• MDR Text Key: 338603794
• Report Number: 1220246-2024-01632
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867305441
• UDI-Public: 00888867305441
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMPLANT SYSTEM, FIBERTAK BUTTON
• Device Catalogue Number: AR-3680
• Device Lot Number: 15199725
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/29/2024
• 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