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

Model Number FIBERTAK

Device Problems Material Fragmentation (1261); Device Dislodged or Dislocated (2923)

Patient Problem Discomfort (2330)

Event Date 05/03/2021

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 the patient had a labral repair on (b)(6) 2020 and had been doing great.In (b)(6) 2021, the patient began to experience a poking sensation in their right shoulder.The patient had an x-ray done and the x-ray image showed two pieces of metal in the patients shoulder.On (b)(6) 2021 a revision surgery was performed to remove the two metal fragments.The metal pieces appear to be from the shaft of the ar-3638 knotless fibertak.

Manufacturer Narrative

The complaint is confirmed.Two fragments from the distal end of an ar-3638 inserter shaft were received for investigation.The remainder of the fibertak assembly was not returned.It was determined that the longest of the two returned fragments (containing the pronged distal tip of the inserter) measured approximately 13.19 mm in length.Both prongs were intact, although the fragment was noticeably bent at the breakage point.The shorter of the two returned inserter shaft fragments measured approximately 4.86 mm in length, and was severely bent.Based on the breakage noted at either end of the shorter fragment, it was determined that this was most likely the segment of the overall inserter shaft that was located directly inferior to the 13.19 mm pronged fragment.Material analysis testing identified that the remnants met material grade specifications for the ar-3638 inserter shaft.Additionally, the thickness of the pronged fragment fell within design tolerance for the ar-3638 inserter distal tip.The method of bone preparation used in the procedure, as well as the bone quality encountered, were not recorded.Based on the observed condition of the returned ar-3638 fragments, this event was most likely the result of prying/leveraging the inserter during insertion, and/or through improper bone preparation prior to insertion.

• Brand Name: FIBERTAK
• Type of Device: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11872431
• MDR Text Key: 252318839
• Report Number: 1220246-2021-03165
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867292123
• UDI-Public: 00888867292123
• Combination Product (y/n): N
• PMA/PMN Number: K130458
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• 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
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/05/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other