BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE, 2.0MM

    MDR report key: 13154799 · Received January 4, 2022

    Report

    Report Number
    1220246-2022-04248
    Event Type
    Malfunction
    Date Received
    January 4, 2022
    Date of Event
    December 8, 2021
    Report Date
    January 4, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867312746
    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.

    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 (B)(6) 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
    1119881 HOLDING SLEEVE, 2.0MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. HOLDING SLEEVE, 2.0MM 1391947 00888867312746

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown