MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK RC, DOUBLOAD TAPE BL/W, BLK/W; NON-DEGRADABLE FIXATION FASTENER

Model Number	FIBERTAK RC, DOUBLOAD TAPE BL/W, BLK/W
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2022
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 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.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force during tensioning and/or improper bone prep.
Event or Problem Description
It was reported that during a pectoral tear shoulder surgery the device tore out.No part of the device broke off.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device by switching to a cork screw procedure.It was not necessary to do a second surgery.

• Brand Name: FIBERTAK RC, DOUBLOAD TAPE BL/W, BLK/W
• Common Device Name: NON-DEGRADABLE FIXATION 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: 19250667
• Report Number: 1220246-2024-02840
• Device Sequence Number: 15062501
• Product Code: MBI
• UDI-Device Identifier: 00888867276901
• UDI-Public: 00888867276901
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200341
• 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): 05/06/2024

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 RC, DOUBLOAD TAPE BL/W, BLK/W
• Device Catalogue Number: AR-3632
• Device Lot Number: 14935047
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2022
• Initial Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown