BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO® LAG SCREW INSERTER

    MDR report key: 20508704 · Received October 22, 2024

    Report

    Report Number
    1220246-2024-08212
    Event Type
    Malfunction
    Date Received
    October 22, 2024
    Date of Event
    October 7, 2024
    Report Date
    January 30, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665036244
    PMA / PMN Number
    K202099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED 5030-000 GALILEO LAG SCREW INSERTER BATCH NUMBER: 220669 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION OF THE RETURNED DEVICE NOTED SLIGHT WEAR AND TEAR WITH FADED LASER MARKINGS. FUNCTIONAL TESTING WAS PERFORMED WITH A KNOWN GOOD 5031-000 GALILEO LAG SCREW LOCKING TOOL BATCH NUMBER: 212675-090 AND IT WAS NOTED THAT THE 5030-000 GALILEO LAG SCREW INSERTER WOULD NOT MATE AND LOCK AS INTENDED. THE SLEEVE OF THE 5030-000 GALILEO LAG SCREW INSERTER WAS NOTED TO BE DAMAGED DURING FUNCTIONAL TESTING. 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 REPETITIVE USE. DATE OF MANUFACTURE: 24-AUG-2022.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ON (B)(6) 2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06680482 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
    2561261 GALILEO® LAG SCREW INSERTER INTRAMED FIXATN ROD AND ACCESS HSB ARTHREX, INC. GALILEO® LAG SCREW INSERTER 220669 00848665036244

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown