BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBERTAK

    MDR report key: 19287544 · Received May 10, 2024

    Report

    Report Number
    1220246-2024-03099
    Event Type
    Malfunction
    Date Received
    May 10, 2024
    Date of Event
    February 16, 2022
    Report Date
    May 10, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867292123
    PMA / PMN Number
    K130458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 IS NOT CONFIRMED. ONE UNPACKAGED AR-3638 WAS RECEIVED FOR INVESTIGATION. THE DIAMETER OF THE FIBERTAK INSERTER WAS ASSESSED USING DIGITAL MICROMETER ID: 224, AND THE DEVICE WAS FOUND TO MEET DESIGN SPECIFICATIONS. NO PROBLEM FOUND.

    Description of Event or Problem · 0

    ON 02/18/2022, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-3638 KNOTLESS FIBERTAK DID NOT GO THROUGH THE GUIDE. A NEW DEVICE WAS OPENED AND USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED 2/21/2022: THIS WAS DISCOVERED DURING A GLENOID LABRUM REPAIR PROCEDURE. ANOTHER AR-3638 KNOTLESS FIBERTAK WAS USED WITH THE GUIDE AND IT WAS SUCCESSFUL. NO ADDITIONAL BONE SOCKET WERE CREATED AND NOTHING BROKE INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2529152 FIBERTAK NON-DEGRADABLE FIXATN FASTENER MBI ARTHREX, INC. FIBERTAK 14501661 00888867292123

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown