BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IBAL UKA, TIBIAL IMPACTOR

    MDR report key: 16361757 · Received February 13, 2023

    Report

    Report Number
    1220246-2023-06270
    Event Type
    Malfunction
    Date Received
    February 13, 2023
    Date of Event
    January 23, 2023
    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 Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED. ONE UNPACKAGED AR-611-4 BATCH NUMBER 052202, WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION FOUND THAT THE HEAD TIBIAL IMPACTOR BROKEN OFF BEFORE RECEIPT FOR INVESTIGATION. NO FRAGMENTS WERE RETURNED FOR ANALYSIS. ADDITIONAL OBSERVATION ALSO FOUND SIGNS OF WEAR. THE ROOT CAUSE OF THE REPORTED FAILURE MODE IS UNDETERMINED; HOWEVER, THE OBSERVED EVENT IS MOST LIKELY CAUSED BY EXCESSIVE FORCES APPLIED DURING USE.

    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

    IT WAS REPORTED ON 01/24/2023 BY A DISTRIBUTOR VIA SEMS THAT AN AR-611-4 TIBIAL IMPACTOR BROKE WHILE BEING IMPACTED. CASE INVOLVEMENT, DEVICE BROKE DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1517223 IBAL UKA, TIBIAL IMPACTOR ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. IBAL UKA, TIBIAL IMPACTOR 00888867223868

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown