BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOBSTER CLAMP, RADIOLUCENT

    MDR report key: 13621176 · Received February 28, 2022

    Report

    Report Number
    1220246-2022-04536
    Event Type
    Malfunction
    Date Received
    February 28, 2022
    Date of Event
    February 11, 2022
    Report Date
    February 28, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867317987
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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.

    Description of Event or Problem · 0

    ON 02/11/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-18700-49 LOBSTER CLAMP BROKE MID CASE, THE DEVICE WAS WARPED AND WHEN THE DOCTOR TRIED TO MANIPULATE IT, THE INSTRUMENT BROKE. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133647 LOBSTER CLAMP, RADIOLUCENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. LOBSTER CLAMP, RADIOLUCENT UNK 00888867317987

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown