BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO® LOCKING TOOL

    MDR report key: 20461895 · Received October 16, 2024

    Report

    Report Number
    1220246-2024-08158
    Event Type
    Malfunction
    Date Received
    October 16, 2024
    Date of Event
    October 7, 2024
    Report Date
    February 4, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665031522
    PMA / PMN Number
    K202099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    501

    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

    COMPLAINT ALLEGATION IS NOT CONFIRMED. ONE UNPACKAGED 5031-000 GALILEO LAG SCREW LOCKING TOOL BATCH NUMBER: 220671-015 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION OF THE RETURNED DEVICE NOTED NORMAL WEAR AND TEAR TO THE DEVICE. FUNCTIONAL TESTING WAS PERFORMED WITH A KNOWN GOOD 5030-000 GALILEO LAG SCREW INSERTER BATCH NUMBER: 212668 AND IT WAS NOTED THAT THE RETURNED 5031-000 GALILEO LAG SCREW LOCKING TOOL WAS ABLE TO MATE AND LOCK AS INTENDED. NO PROBLEM FOUND.

    Description of Event or Problem · 0

    ON 10/07/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A 5030-000 GALILEO LAG SCREW AND A 5031-000 GALILEO LOCKING TOOL DISENGAGED WHEN COMPRESSION WAS APPLIED RESULTING IN THE INSTRUMENTS NOT LOCKING. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1425265 GALILEO® LOCKING TOOL INTRAMED FIXATN ROD AND ACCESS HSB ARTHREX, INC. GALILEO® LOCKING TOOL 220671 00848665031522

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown