BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASEPLATE IMPACTOR, ASSEMBLY

    MDR report key: 19510967 · Received June 11, 2024

    Report

    Report Number
    1220246-2024-05559
    Event Type
    Malfunction
    Date Received
    June 11, 2024
    Date of Event
    May 16, 2024
    Report Date
    September 10, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867136731
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-9165CDG BATCH NUMBER 052210 WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION REVEALED THAT THE BLUE BASEPLATE ADAPTER HAD BROKEN OFF. IT WAS ALSO NOTED THAT THE LASER MARKS WERE FADING, AND SCRATCHES WERE PRESENT ON THE SHAFT. NO FUNCTIONAL TESTING WAS PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE REPORTED CONDITION IS MOST LIKELY CAUSED BY OVERSTRESSING A DEVICE THAT IS DAMAGED NATURALLY AND INEVITABLY AS A RESULT OF NORMAL WEAR OR AGING.

    Description of Event or Problem · 0

    ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 3) OF AN AR-9165CDG UNIVERS REVERS UNIVERSAL BASEPLATE IMPACTOR BLUE PLASTIC TIPS WAS FOUND TO BE BROKEN AFTER THE CASE, DURING CLEANING FROM AN RTSA PROCEDURE ON (B)(6) 2024. THE ISSUE DID NOT DISRUPT THE CASE OR CAUSE ANY NEGATIVE IMPACT ON THE PATIENT, AND THE CASE WAS COMPLETED AS NORMAL. THIS WAS DISCOVERED AFTER USE, AND NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1524916 BASEPLATE IMPACTOR, ASSEMBLY ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. BASEPLATE IMPACTOR, ASSEMBLY 052233 00888867136731

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown