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

Model Number FIBERTAK

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 06/15/2022

Event Type  malfunction  

Event Description

On 6/17/2022, it was reported by a sales representative via email that an ar-3638 knotless fibertak was implanted using the appropriate reusable curved drill guide and drill.Upon lightly setting the anchor, it was apparent that the white and black traction stitch, used to complete the knotless splice, had been displaced and was visible outside of the bone socket created.The surgeon chose to continue with a capsular plication using the repair stitch.When completing the splice, the knotless splice was not able to be tightened down all the way and became loose.At this point, the anchor was no longer effective at reducing tissue.The fibertak anchor came out in pieces and was not recoverable.Surgeon then over drilled the prepared bone socket, and inserted a ar-1938bc bio-composite suturetak to complete the case.This was discovered during an mdi instability procedure.

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.

• 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: 14914924
• MDR Text Key: 301549270
• Report Number: 1220246-2022-05174
• 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: 14942993
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2022
• Date Device Manufactured: 03/24/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1