BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IBAL UKA, TIBIAL IMPACTOR

    MDR report key: 21011630 · Received December 24, 2024

    Report

    Report Number
    1220246-2024-09036
    Event Type
    Malfunction
    Date Received
    December 24, 2024
    Date of Event
    November 26, 2024
    Report Date
    May 28, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. THE COMPLAINT ALLEGATION WAS CONFIRMED. ONE UNPACKAGED AR-611-4 BATCH NUMBER 051752, WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION FOUND THAT THE IMPACTOR HEAD IS BROKEN OFF. THE SHAFT OF THE DEVICE HAS SCRATCHES AND DISCOLORATION SPOTS. EVALUATION OF THE RETURNED PIECE OF THE IMPACTOR HEAD FOUND GOUGES AND DAMAGED TO THE MATERIAL. FUNCTIONAL TESTING CANNOT BE PERFORMED AS THE DEVICE IS DAMAGED. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS WEAR AND TEAR OF THE DEVICE AS THE MANUFACTURING DATED IS FEBRUARY 15, 2018.

    Description of Event or Problem · 0

    ON (B)(6)2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9512 UNIVERSAL REVS STEM/CUP EXTRACT ADAPTER HANDLE AND AN AR-611-4 TIBIAL IMPACTOR WERE BOTH BROKEN. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2510025 IBAL UKA, TIBIAL IMPACTOR ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. IBAL UKA, TIBIAL IMPACTOR 051752

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown