BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOBSTER CLAMP, RADIOLUCENT

    MDR report key: 13154695 · Received January 4, 2022

    Report

    Report Number
    1220246-2022-04245
    Event Type
    Malfunction
    Date Received
    January 4, 2022
    Date of Event
    December 8, 2021
    Report Date
    January 26, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867317987
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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

    COMPLAINT CONFIRMED, THE DEVICE RETURNED WAS FOUND TO BE BROKEN IN TWO, SPECIFICALLY COMPONENT #1. THE CAUSE OF THE EVENT IS UNDETERMINED, HOWEVER A LIKELY CAUSE IS USER-APPLIED MECHANICAL FORCES.

    Description of Event or Problem · 0

    ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-18700-49, THE PLASTIC LOBSTER CLAWS SNAPPED, AND THE AR-18700-25 SCREW FROM THE HOLDING SLEEVE RUSTED THROUGH. THIS WAS DISCOVERED DURING USE IN A PROCEDURE. NO PATIENT AFFECT REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. REQUESTED ADDITIONAL INFORMATION 12/15/2021. ON 12/15/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THE PLASTIC LOBSTER CLAW WASN¿T CLAMPING AND WAS FALLING APART DURING USE. THE SCREW RETENTION SLEEVE FALL INTO TWO PIECES. THE CASE WAS ON (B)(6) WITH DR. (B)(6) FINGER FRACTURE. THE CASE WAS COMPLETED USING JUST AN EXTERNAL FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119879 LOBSTER CLAMP, RADIOLUCENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. LOBSTER CLAMP, RADIOLUCENT 34801932 00888867317987

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown