BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLKMANN BONE HK,9" LNGX 20MM DEEP,SHARP

    MDR report key: 15093185 · Received July 25, 2022

    Report

    Report Number
    1220246-2022-05277
    Event Type
    Malfunction
    Date Received
    July 25, 2022
    Date of Event
    July 6, 2022
    Report Date
    September 9, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867138414
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    501

    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. ONE UNPACKAGED AR-9260-38 WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION IDENTIFIED THE TIP OF THE DEVICE HAD BROKEN. WITHOUT ADDITIONAL INFORMATION, THE CAUSE REMAINS UNDETERMINED. A PROBABLE CAUSE COULD BE ATTRIBUTED TO IMPACTING THE DEVICE AGAINST A HARD SURFACE, SUCH AS BONE, OR ANOTHER DEVICE.

    Description of Event or Problem · 0

    ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9260-38 VOLKMANN BONE HOOK TIP BROKE. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116886 VOLKMANN BONE HK,9" LNGX 20MM DEEP,SHARP ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. VOLKMANN BONE HK,9" LNGX 20MM DEEP,SHARP 00888867138414

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown