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

Model Number IMPLANT SYSTEM, FIBERTAK BUTTON

Device Problem Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Date 03/17/2021

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

It was reported that during a procedure, when the surgeon went to tension the sutures of the ar-3680, the anchor would pull out.The surgeon used a second ar-3680 and the same issue occurred.All fragments were removed and the case was completed by using a third ar-3680.

• Brand Name: IMPLANT SYSTEM, FIBERTAK BUTTON
• Type of Device: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 12075550
• MDR Text Key: 261474256
• Report Number: 1220246-2021-03321
• 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: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• 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: 12353421
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2021
• Date Device Manufactured: 12/22/2020
• 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