BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICK, 45 DEG

    MDR report key: 15040488 · Received July 18, 2022

    Report

    Report Number
    1220246-2022-05242
    Event Type
    Malfunction
    Date Received
    July 18, 2022
    Date of Event
    June 28, 2022
    Report Date
    September 9, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    GFA
    UDI-DI
    00888867042919
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS CONFIRMED. FOUR AR-8150PP-45 WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION NOTED ONE DEVICE HAD ITS LEVER BROKEN OFF, AND THE BROKEN LEVER HAD NOT BEEN RETURNED. ANOTHER DEVICE HAD THE CURVED PART OF THE SHAFT SLIGHTLY BENT. IT WAS ALSO NOTED THAT THE LEVERS WERE THE INCORRECT COMPONENT. PER AR-8150PP-45 BOM, THE REQUIRED LEVER COMPONENT IS C1206-01, BUT THE LEVERS PRESENT ARE 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. IT IS LIKELY THAT THE OPERATOR ENCOUNTERED A STUCK LEVER AND, APPLYING EXCESSIVE FORCE, BROKE ONE OF THE LEVERS. THE CAUSE FOR THE BROKEN LEVER IS THUS ATTRIBUTED TO MISUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY THE HANDLES OF THE FOUR DEVICES BROKE. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE FROM ANOTHER MANUFACTURER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 30-JUN-2022 IT WAS CONFIRMED THAT THE PLASTIC HANDLE BROKE, WHICH PREVENTED THE WIRE FROM SLIDING OUT. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944548 POWERPICK, 45 DEG BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA ARTHREX, INC. POWERPICK, 45 DEG 11561427 00888867042919

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown