BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASEPLATE IMPACTOR, ASSEMBLY

    MDR report key: 21410948 · Received February 19, 2025

    Report

    Report Number
    1220246-2025-00544
    Event Type
    Malfunction
    Date Received
    February 19, 2025
    Date of Event
    December 26, 2024
    Report Date
    February 19, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867136731
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-9165CDG UNIVERS REVERS¿ UNIVERSAL BASEPLATE IMPACTOR BATCH NUMBER: 052233 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION NOTED THAT THE BLUE BASEPLATE ADAPTER WAS DAMAGED, AND A FRAGMENT HAD BROKEN OFF. IT WAS FURTHER OBSERVED THAT THE DEVICE HAD IMPACTION MARKS ON THE SHAFT AND THE PROXIMAL END WAS DAMAGED. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE/MISHANDLING DUE TO THE DAMAGE TO THE DEVICE. REFER TO INVESTIGATION PHOTOS.

    Description of Event or Problem · 0

    ON (B)(6) 2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9545-T15-01, (QTY. 4) OF AN AR-9545-T15-02, AR-9545-T15-03 DRIVER SHAFTS AND AN AR-9165CDG BASEPLATE IMPACTOR ASSEMBLY DRIVER ENDS WERE TWISTED. UPON INSERTING THE PERIPHERAL LOCKING SCREWS FOR THE BASEPLATE, THE DRIVER END WOULD TWIST FROM THE TORQUE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2540165 BASEPLATE IMPACTOR, ASSEMBLY ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. BASEPLATE IMPACTOR, ASSEMBLY 052233 00888867136731

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown