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

Model Number FIBERTAK

Device Problems Device Slipped (1584); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 05/03/2022

Event Type  malfunction  

Event Description

On 05/04/2022, it was reported by a sales representative via phone that (3) ar-3638 fibertaks failed.This occurred on (b)(6) 2022 during a bankart repair when the surgeon cycled the drill bit too many times resulting in the implant backing out.A second anchor was implanted properly into the same hole however it cinched up 3/4 of the way, and would not lock.The anchor remained implanted, and the sutures were cut out.A third implant was used and cycled too many times and resulted in the device backing out.The case was completed using 3 more fibertaks that were not cycled more than they should be and were implanted successfully.There was no patient effect reported.Additional information provided on 05/04/2022 that the 1.8 mm solid drill bit from the perc kit that was being used.The patient had a little softer bone quality.During returned device evaluation, a reportable malfunction was discovered.

Manufacturer Narrative

During returned device evaluation, a reportable malfunction was discovered.The complaint is unable to be confirmed.Two unpackaged ar-3638 inserters were received for investigation.Visual inspection identified that neither of the two c16235-10 suture tape assemblies corresponding to the returned inserters were returned for analysis.As such, the implant failure allegations cannot be verified.It was noted that one of the two prongs at the distal tip of one of the inserters had broken off.No fragments were returned.The cause remains undetermined.The method used to prepare the bone, as well as the bone quality encountered, were not provided.The thickness of the broken inserter tip was assessed using digital micrometer id: 224, and was found to meet design specifications.

• Brand Name: FIBERTAK
• 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: 14914742
• MDR Text Key: 303573645
• Report Number: 1220246-2022-05169
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867292123
• UDI-Public: 00888867292123
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181769
• 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: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FIBERTAK
• Device Catalogue Number: AR-3638
• Device Lot Number: 14930375
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1