BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASEPLATE IMPACTOR, ASSEMBLY

    MDR report key: 18621602 · Received February 1, 2024

    Report

    Report Number
    1220246-2024-00657
    Event Type
    Malfunction
    Date Received
    February 1, 2024
    Date of Event
    July 17, 2023
    Report Date
    February 1, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867136731
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED. ONE UNPACKAGED AR-9165CDG BATCH NUMBER 052224 WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION IDENTIFIED THAT THE BLUE BASEPLATE ADAPTER HAD BROKEN OFF. IT WAS NOTED THAT THE LASER MARKS WERE FADING. THE MOST LIKELY REASON FOR THE REPORTED FAILURE IS THE WEAR AND TEAR DAMAGE INCURRED OVER REPEATED USAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SHOULDER PROSTHESIS SURGERY THE DRIVER ATTACHMENT BECAME BENT / BROKE AWAY AND THE BLUE TIP AT THE FRONT OF THE SECOND DEVICE BROKE OFF. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE, KHE, 08-AUG-2023 FURTHER INFORMATION WAS RECEIVED WITH THE DEVICE. IT WAS REPORTED THAT THE BLUE ATTACHMENT IS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414885 BASEPLATE IMPACTOR, ASSEMBLY ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. BASEPLATE IMPACTOR, ASSEMBLY 052224 00888867136731

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown