MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK; NON-DEGRADABLE FIXATN FASTENER

Model Number	FIBERTAK
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to user error of the device due to excessive force used during suture passing/tightening /tensioning.
Event or Problem Description
It was reported that during a bankart repair surgery the sutures of all 5 fibertak anchors would not pull through themselves.The pull-through suture did not run on all devices.No part of the device broke.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: FIBERTAK
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: jared engle ; 8009337001
• MDR Report Key: 19519333
• Report Number: 1220246-2024-05606
• Device Sequence Number: 6030774
• Product Code: MBI
• UDI-Device Identifier: 00888867290945
• UDI-Public: 00888867290945
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K130458
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FIBERTAK
• Device Catalogue Number: AR-3638-1
• Device Lot Number: 14958977
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown