BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IBAL UKA, TIBIAL IMPACTOR

    MDR report key: 21365899 · Received February 12, 2025

    Report

    Report Number
    1220246-2025-00408
    Event Type
    Malfunction
    Date Received
    February 12, 2025
    Date of Event
    December 23, 2024
    Report Date
    March 4, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867223868
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED, AR-611-4, IBALANCE® UKA SPORTSPLASTY¿, TIBIAL IMPACTOR, BATCH NUMBER: 051752, WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION OF THE RETURNED DEVICE NOTED THAT FRAGMENTS FROM THE DISTAL END HAD BROKEN OFF. ADDITIONALLY, THE IMPACTOR HEAD HAD SIGNIFICANT DAMAGE: STRIKE MARKS AND DISCOLORATION. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO OVERSTRESSING A DEVICE THAT IS DAMAGED NATURALLY AND INEVITABLY AS A RESULT OF NORMAL WEAR OR AGING FROM REPEATED USAGE/REPROCESSING. MANUFACTURED DATE: 15-FEB-2018.

    Description of Event or Problem · 0

    ON 12/23/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT AN AR-611-4 TIBIAL IMPACTOR BROKE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856721 IBAL UKA, TIBIAL IMPACTOR ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. IBAL UKA, TIBIAL IMPACTOR 051752 00888867223868

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown