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

Model Number FIBERTAK

Device Problem Device Slipped (1584)

Event Date 02/25/2022

Event Type  Injury  

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 (b)(6) 2022, it was reported by a sales representative via phone that 4 out of 9 ar-3638 fibertaks pulled out of implantation site.The surgeon used 3 pushlocks to complete the case without further issues.This was discovered during a revision bankart procedure on (b)(6) 2022.Surgeon stated that the original implanted sutures had torn and were not holding the labrum down, which lead to the bankart procedure to be performed.The sales representative does not know when or where the original procedure took place.Surgeon who performed this revision procedure is not the same surgeon who performed the original procedure.It could not be confirmed either if the implants were arthrex devices, however, nothing got explanted, only the sutures were cut.The original anchors were implanted deep in the bone and could not be removed.No further details were given regarding the original procedure.

• 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: 13758069
• MDR Text Key: 287178898
• Report Number: 1220246-2022-04601
• 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: K130458
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Administrator/Supervisor
• Report Date: 03/14/2022

1 Device was Involved in the Event

• Date FDA Received: 03/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FIBERTAK
• Device Catalogue Number: AR-3638
• Device Lot Number: 14683240
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial