BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBERTAK

    MDR report key: 19247582 · Received May 6, 2024

    Report

    Report Number
    1220246-2024-02799
    Event Type
    Malfunction
    Date Received
    May 6, 2024
    Date of Event
    August 27, 2021
    Report Date
    May 6, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867292123
    PMA / PMN Number
    K130458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    501

    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 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.

    Description of Event or Problem · 0

    ON (B)(6) 2021 IT WAS REPORTED BY SALES REP VIA EMAIL THAT AN AR-3638 KNOTLESS FIBERTAK¿ WOULD NOT SHUTTLE AS THE PASSING SUTURE WAS THREATED THROUGH THE REPAIR STITCH, AFTER IMPLANTING ANCHOR. SURGEON ENDED UP CUTTING ANCHOR OUT AND OPENED A NEW ONE SUCCESSFULLY. THIS WAS DISCOVERED DURING A LABRAL REPAIR. NO PATIENT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613609 FIBERTAK NON-DEGRADABLE FIXATN FASTENER MBI ARTHREX, INC. FIBERTAK 12642536 00888867292123

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown