BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IBALANCE TKA, HANDLE, MODULAR KEEL PUNCH

    MDR report key: 17566778 · Received August 17, 2023

    Report

    Report Number
    1220246-2023-07535
    Event Type
    Malfunction
    Date Received
    August 17, 2023
    Date of Event
    July 19, 2023
    Report Date
    November 4, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867115941
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    501

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS CONFIRMED. ONE UNPACKAGED AR-613-1 SERIAL/BATCH NUMBER 051916 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION FOUND THE HANDLED WAS CRACKED. SIGNS OF WEAR AND TEAR. THE MOST LIKELY REASON FOR THE REPORTED FAILURE IS THE WEAR AND TEAR DAMAGE INCURRED OVER REPEATED USAGE.

    Description of Event or Problem · 0

    ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-613-1 IBALANCE TKA, HANDLE, MODULAR KEEL PUNCH HAD AN ISSUE. DURING A TKA PROCEDURE ON (B)(6) 2023, THE SURGEON NOTICED THE HANDLE ON THE KEELED QUICK CONNECT WAS CRACKED. THE CASE WAS FINISHED WITH ANOTHER AR-613-1. THIS WAS DISCOVERED DURING USE, WITH NO REPORTED ADVERSE EVENT OR PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994199 IBALANCE TKA, HANDLE, MODULAR KEEL PUNCH MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. IBALANCE TKA, HANDLE, MODULAR KEEL PUNCH 051916 00888867115941

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown