BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASEPLATE IMPACTOR, ASSEMBLY

    MDR report key: 18591669 · Received January 26, 2024

    Report

    Report Number
    1220246-2024-00571
    Event Type
    Malfunction
    Date Received
    January 26, 2024
    Date of Event
    January 4, 2024
    Report Date
    February 19, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867136731
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6. THE COMPLAINT IS CONFIRMED. ONE UNPACKAGED AR-9165CDG BATCH NUMBER 052027 WAS RECEIVED FOR INVESTIGATION. UPON VISUAL INSPECTION, IT WAS IDENTIFIED THAT THE BLUE BASEPLATE ADAPTER HAD BROKEN OFF. IT WAS NOTED THAT THE LASER MARKS ON THE BLUE BASEPLATE WERE FADED. THE REPORTED CONDITION IS MOST LIKELY CAUSED BY USER ERROR OVERSTRESSING A DEVICE THAT IS DAMAGED NATURALLY AND INEVITABLY AS A RESULT OF NORMAL WEAR OR AGING.

    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 01/04/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9165CDG BASEPLATE IMPACTOR WAS BROKEN. THIS OCCURRED AFTER USE IN A CASE WITH NO PATIENT EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826388 BASEPLATE IMPACTOR, ASSEMBLY ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. BASEPLATE IMPACTOR, ASSEMBLY 052027 00888867136731

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown