BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO® LAG SCREW INSERTER

    MDR report key: 19378372 · Received May 22, 2024

    Report

    Report Number
    1220246-2024-03689
    Event Type
    Malfunction
    Date Received
    May 22, 2024
    Date of Event
    April 24, 2024
    Report Date
    September 16, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665036244
    PMA / PMN Number
    K202099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    ADDITIONAL INFORMATION: D9, G3, H3, H6. THE COMPLAINT ALLEGATION WAS CONFIRMED. ONE UNPACKAGED 5030-000 BATCH 220095 WAS RECEIVED FOR INVESTIGATION. FUNCTIONAL TESTING COULD NOT BE CONDUCTED AS THE DEVICE WAS DAMAGED. UPON VISUAL INSPECTION, THE GOLD CONNECTOR WAS NOT WORKING AS INTENDED, RENDERING THE DEVICE INOPERATIVE. 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 04/24/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT A 5030-000 GALILEO LAG SCREW INSERTERS GOLD RELEASE MECHANISM BROKE. THIS OCCURRED DURING A CASE WHEN A METAL PIECE APPEARED ON THE X-RAY, AND THEY COULD NOT ADVANCE THE SCREW ANY FURTHER. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1749547 GALILEO® LAG SCREW INSERTER INTRAMED FIXATN ROD AND ACCESS HSB ARTHREX, INC. GALILEO® LAG SCREW INSERTER 220095 00848665036244

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown