BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IBAL UKA, TIBIAL IMPACTOR

    MDR report key: 19387591 · Received May 23, 2024

    Report

    Report Number
    1220246-2024-03780
    Event Type
    Malfunction
    Date Received
    May 23, 2024
    Date of Event
    June 16, 2021
    Report Date
    May 23, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867223868
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 AR-611-4 LOT 051851 WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION OF THE DEVICE SHOWED THAT THE HEAD OF THE DEVICE (C10724-01) HAS BROKEN OFF AND ONLY A PORTION REMAINS. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE IS USER ERROR FOR APPLYING EXCESSIVE FORCE DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED ON 8/27/2021 BY A SALES REP VIA EMAIL THAT ON (B)(6) 2021 AN AR-611-4 IBALANCE® TIBIAL IMPACTOR WAS BEING USED IN A CASE. AFTER USE, THE IMPACTOR BROKE. NO ISSUES WITH THE PATIENT, IT JUST BROKE. NO FURTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1862270 IBAL UKA, TIBIAL IMPACTOR ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. IBAL UKA, TIBIAL IMPACTOR 051851 00888867223868

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown