BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO® CAPTURING ROD

    MDR report key: 17876557 · Received October 5, 2023

    Report

    Report Number
    1220246-2023-08067
    Event Type
    Malfunction
    Date Received
    October 5, 2023
    Date of Event
    September 6, 2023
    Report Date
    February 1, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665039177
    PMA / PMN Number
    K202099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT IS CONFIRMED. FUNCTIONAL TESTING WAS NOT PERFORMED ON THE RETURNED 5033-100 DUE TO THE DAMAGE TO THE TIP OF THE DEVICE. VISUAL EVALUATION NOTED THAT THE TIP OF THE DEVICE IS BROKEN OFF AND WAS RETURNED. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USE ERROR DUE TO EXCESSIVE USER-APPLIED MECHANICAL FORCES.

    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.

    Description of Event or Problem · 0

    ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06023115 THAT AN 5033-100 GALILEO® CAPTURING ROD BROKE. THIS OCCURRED DURING A CASE, ALL FRAGMENTS WERE RETRIEVED AND THE CASE CONTINUED USING ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2261685 GALILEO® CAPTURING ROD ORTHOPEDIC MANUAL SURG INSTR HSB ARTHREX, INC. GALILEO® CAPTURING ROD UNK 00848665039177

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown