BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO® LAG SCREW INSERTER

    MDR report key: 19569446 · Received June 19, 2024

    Report

    Report Number
    1220246-2024-06187
    Event Type
    Malfunction
    Date Received
    June 19, 2024
    Date of Event
    October 13, 2021
    Report Date
    June 19, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665036244
    PMA / PMN Number
    K202099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. COMPLAINT CONFIRMED. ONE UNPACKAGED 5030-000, BATCH 212668 WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION IDENTIFIED THAT THE HANDLE DISENGAGE COMPONENT HAD BROKEN FROM THE PROXIMAL END OF THE LAG SCREW INSERTER. THE COIL, AS WELL AS THE INNER DIAMETER OF THE DISENGAGE COMPONENT, APPEARED DAMAGED. THE MOST LIKELY CAUSE CAN BE ATTRIBUTED TO USER-APPLIED MECHANICAL FORCES, SUCH AS THROUGH OVER-ENGAGING THE COMPONENT DURING USE.

    Description of Event or Problem · 0

    ON 10/13/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN 5030-000 LAG SCREW INSERTER BROKE. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549178 GALILEO® LAG SCREW INSERTER ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ARTHREX, INC. GALILEO® LAG SCREW INSERTER 212668 00848665036244

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown