BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IBAL UKA, TIBIAL IMPACTOR

    MDR report key: 19411946 · Received May 28, 2024

    Report

    Report Number
    1220246-2024-04159
    Event Type
    Malfunction
    Date Received
    May 28, 2024
    Date of Event
    November 21, 2022
    Report Date
    May 28, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    501

    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. COMPLAINT IS CONFIRMED. ONE UNPACKAGED AR-611-4 BATCH NUMBER 051930, WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION FOUND THAT THE HEAD TIBIAL IMPACTOR HAD CRACKED BEFORE RECEIPT FOR INVESTIGATION. ADDITIONAL OBSERVATION ALSO FOUND SIGNS OF WEAR, SCRATCHES, AND SURFACE IRREGULARITIES ON THE HEAD TIBIAL IMPACTOR. THE SHAFT OF THE DEVICE ALSO HAS SCRATCHES AND MARKS. THE OBSERVED CONDITION IS MOST LIKELY THE RESULT OF HEAVY USE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS WEAR AND TEAR.

    Description of Event or Problem · 0

    ON 11/21/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A TIBIAL IMPACTOR IS CRACKED. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1939102 IBAL UKA, TIBIAL IMPACTOR ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. IBAL UKA, TIBIAL IMPACTOR 051930

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown