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 Insufficient Information (4580)

Event Date 02/28/2024

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.Investigation is in process.A follow-up report will be provided upon availability of additional information.

Event Description

On 2/28/2024, it was reported by a sales representative via email that the sutures from an ar-380 fibertak button implant system broke, and the anchor split.This was discovered during a distal biceps procedure on (b)(6) 2024.Everything was removed from inside the patient and the case was completed using another ar-3680 fibertak button implant system.

• 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: 18921765
• MDR Text Key: 337874063
• Report Number: 1220246-2024-01523
• 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: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• 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: 15199732
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2024
• 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