BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOBSTER CLAMP, RADIOLUCENT

    MDR report key: 14915064 · Received July 5, 2022

    Report

    Report Number
    1220246-2022-05178
    Event Type
    Malfunction
    Date Received
    July 5, 2022
    Date of Event
    June 16, 2022
    Report Date
    July 12, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867317987
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 BASED ON THE CUSTOMER PROVIDED PHOTO, WHICH DISPLAYS THE BROKEN DEVICE. WITHOUT RETURN OF THE DEVICE FOR PHYSICAL EVALUATION, THE CAUSE REMAINS UNDETERMINED. NO CHANGE IN HARM WAS IDENTIFIED.

    Description of Event or Problem · 0

    ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-18700-49 LOBSTER CLAMP WAS BEING USED IN AN UNKNOWN CASE TO REDUCE THE FRACTURE, AND ONE OF THE TIPS BROKE-OFF. THE FRAGMENT WAS RETRIEVED. THE CASE WAS COMPLETED, WITH NO PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1450241 LOBSTER CLAMP, RADIOLUCENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. LOBSTER CLAMP, RADIOLUCENT 34801932 00888867317987

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown