BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO LAG SCREW, RIGHT, Ø10.5MMX110MM

    MDR report key: 19493896 · Received June 8, 2024

    Report

    Report Number
    1220246-2024-05296
    Event Type
    Malfunction
    Date Received
    June 8, 2024
    Date of Event
    May 8, 2024
    Report Date
    June 11, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665015874
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    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

    BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR DUE TO MISALIGNED INSERTION AND/OR IMPROPER BONE PREPARATION.

    Description of Event or Problem · 0

    ON 05/09/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN 1192-100 TELESCOPING LAG SCREW, A 1099-110 TELESCOPING LAG SCREW, AND A 1099-100 TELESCOPING LAG SCREW WOULD NOT ADVANCE INTO THE FEMORAL HEAD OF AN AR-9094-10-2030 TROCHANTERIC NAIL. THE TELESCOPING LAG SCREWS WERE USED WITH A NEW TROCHANTERIC NAIL; HOWEVER, THE ISSUE PERSISTED, AND THE TELESCOPING LAG SCREWS WOULD STILL NOT ADVANCE. THE CASE WAS COMPLETED USING A NEW TROCHANTERIC NAIL AND A NEW 1099-110 TELESCOPING LAG SCREW. THE CASE WAS DELAYED ABOUT FIFTEEN MINUTES. THIS WAS DISCOVERED DURING A LEFT HIP IM NAIL PROCEDURE ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012861 GALILEO LAG SCREW, RIGHT, Ø10.5MMX110MM INTRAMED FIXATN ROD AND ACCESS HSB ARTHREX, INC. GALILEO LAG SCREW, RIGHT, Ø10.5MMX110MM UNK 00848665015874

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown