BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBERTAK

    MDR report key: 19567141 · Received June 19, 2024

    Report

    Report Number
    1220246-2024-06109
    Event Type
    Malfunction
    Date Received
    June 19, 2024
    Date of Event
    August 25, 2021
    Report Date
    June 19, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867292123
    PMA / PMN Number
    K130458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 IS NOT CONFIRMED. ONE UNPACKAGED AR-3638 WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION IDENTIFIED NO DAMAGE TO THE INSERTER, WITH FRAYING PRESENT AT THE END OF ONE SUTURE CONSTRUCT. THE DIAMETER OF THE INSERTER WAS ASSESSED USING DIGITAL MICROMETER ID: 224, AND IT WAS IDENTIFIED THAT THE DEVICE MET DESIGN SPECIFICATIONS. THE IMPLANT WAS NOT RETURNED FOR ANALYSIS. NO PROBLEM FOUND.

    Description of Event or Problem · 0

    ON 8/31/2021 IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-3638, KNOTLESS FIBERTAK GOT STUCK IN THE GUIDE WHEN SURGEON TRIED TO INSERT IMPLANT. THIS WAS DISCOVERED DURING A PROCEDURE; A NEW PRODUCT WAS USED AND CASE WAS SUCCESSFULLY COMPLETED. NO PATIENT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673643 FIBERTAK NON-DEGRADABLE FIXATN FASTENER MBI ARTHREX, INC. FIBERTAK 13348699 00888867292123

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown