BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IBAL UKA, TIBIAL IMPACTOR

    MDR report key: 15758580 · Received November 9, 2022

    Report

    Report Number
    1220246-2022-05719
    Event Type
    Malfunction
    Date Received
    November 9, 2022
    Date of Event
    October 20, 2022
    Report Date
    March 13, 2023
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867223868
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT IS CONFIRMED. ONE UNPACKAGED AR-611-4 BATCH NUMBER 051843, WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION FOUND THAT THE HEAD TIBIAL IMPACTOR HAD BROKEN OFF AT THE DISTAL END OF AR-611-4. NO FRAGMENTS WERE RETURNED FOR INVESTIGATION. ADDITIONAL OBSERVATION ALSO FOUND SIGNS OF WEAR, AS WELL AS MULTIPLE DISCOLORATION SPOTS. THE CAUSE REMAINS UNDETERMINED. HOWEVER, THE OBSERVED CONDITION IS MOST LIKELY THE RESULT OF WEAR AND TEAR INCURRED OVER REPEATED USAGE.

    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 (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-611-4 TIBIAL IMPACTOR IS BROKEN. THIS OCCURRED DURING AN UNKNOWN CASE, WITH NO PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2948254 IBAL UKA, TIBIAL IMPACTOR ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. IBAL UKA, TIBIAL IMPACTOR 051843 00888867223868

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown