BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAT DECUBITUS SHOULDR TRACN DEV

    MDR report key: 19164083 · Received April 23, 2024

    Report

    Report Number
    1220246-2024-02247
    Event Type
    Malfunction
    Date Received
    April 23, 2024
    Date of Event
    April 19, 2021
    Report Date
    April 23, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    KQZ
    UDI-DI
    00888867020368
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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. VENDOR EVALUATION CONFIRMED THE COMPLAINT, MULTIPLE COMPONENTS ARE DAMAGED. THE CAUSE IS LISTED AS WEAR AND TEAR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SHEATH COVERING THE CABLES HAS COME APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1084086 LAT DECUBITUS SHOULDR TRACN DEV TRACTION APPARATUS KQZ ARTHREX, INC. LAT DECUBITUS SHOULDR TRACN DEV 10558282 00888867020368

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown