BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IBAL UKA, TIBIAL IMPACTOR

    MDR report key: 19434623 · Received May 31, 2024

    Report

    Report Number
    1220246-2024-04510
    Event Type
    Malfunction
    Date Received
    May 31, 2024
    Date of Event
    April 19, 2023
    Report Date
    May 31, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. THE COMPLAINT IS CONFIRMED. ONE UNPACKAGED AR-611-4 BATCH NUMBER 052202, WAS RECEIVED FOR INVESTIGATION. THE VISUAL INSPECTION IDENTIFIED THAT THE HEAD TIBIAL IMPACTOR HAD A BROKEN CHUCK PIECE. NO FRAGMENTS WERE RETURNED FOR ANALYSIS. ADDITIONAL OBSERVATION ALSO FOUND SIGNS OF WEAR AND SCRATCHES. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO PRYING/LEVERAGING THE DEVICE AGAINST HARD BONE OR OTHER INSTRUMENTATION DURING USE.

    Description of Event or Problem · 0

    ON 04/19/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-611-4 TIBIAL IMPACTOR BROKE. THIS WAS DISCOVERED DURING A CASE; DEVICE BROKE DURING USE. ADDITIONAL INFORMATION REQUESTED ON 4/21/2023. DEVICE DID NOT BREAK INSIDE PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1453764 IBAL UKA, TIBIAL IMPACTOR ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. IBAL UKA, TIBIAL IMPACTOR 052202

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown