BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASEPLATE IMPACTOR, ASSEMBLY

    MDR report key: 21036026 · Received December 30, 2024

    Report

    Report Number
    1220246-2024-09112
    Event Type
    Malfunction
    Date Received
    December 30, 2024
    Date of Event
    December 4, 2024
    Report Date
    February 14, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867136731
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-9165CDG UNIVERS REVERS¿ UNIVERSAL BASEPLATE IMPACTOR BATCH NUMBER 052233 WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION IDENTIFIED THAT THE BLUE BASEPLATE ADAPTER HAD BROKEN OFF. IT WAS NOTED THAT THE LASER MARKS WERE FADING. FUNCTIONAL TESTING CANNOT BE PERFORMED AS THE DEVICE WAS RECEIVED DAMAGED. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS WEAR AND DAMAGE DUE TO REPEATED USE AND/OR REPROCESSING.

    Description of Event or Problem · 0

    ON 12/04/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT (QTY. (B)(4)) OF AN AR-9165CDG BASEPLATE IMPACTOR ASSEMBLY DRILL GUIDE AND IMPACTORS HAD DAMAGED TIPS. THIS WAS DISCOVERED DURING THE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2420239 BASEPLATE IMPACTOR, ASSEMBLY ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. BASEPLATE IMPACTOR, ASSEMBLY 052233 00888867136731

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown