BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICK, 30 DEG

    MDR report key: 19311072 · Received May 14, 2024

    Report

    Report Number
    1220246-2024-03243
    Event Type
    Malfunction
    Date Received
    May 14, 2024
    Date of Event
    July 1, 2022
    Report Date
    May 14, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    GFA
    UDI-DI
    00888867042902
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS CONFIRMED. ONE AR-8150PP-30 WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION NOTED THAT THE LEVER WAS THE INCORRECT COMPONENT. PER AR-8150PP-30 BOM, THE REQUIRED LEVER COMPONENT IS C1206-01, BUT THE LEVER PRESENT IS C-3901-01. THE INCORRECT LEVERS ARE A KNOWN ISSUE AFFECTING THIS BATCH. THE ISSUE WAS ADDRESSED IN NCR-15261 AND AN EVENT RISK ASSESSMENT WAS PERFORMED AND RECORDED AS PLM66913. THE INCORRECT LEVERS PREVENT THEIR NORMAL OPERATION, SOMETIMES GETTING STUCK.

    Description of Event or Problem · 0

    IT WAS REPORTED ON 07/01/2022 BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-8150PP-30 POWERPICK LEVER WAS STUCK AND NEEDLE WAS JAMMED. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648313 POWERPICK, 30 DEG BURR, SURGICAL GFA ARTHREX, INC. POWERPICK, 30 DEG 14041117 00888867042902

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown