BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO® LAG SCREW INSERTER

    MDR report key: 19566162 · Received June 19, 2024

    Report

    Report Number
    1220246-2024-06069
    Event Type
    Malfunction
    Date Received
    June 19, 2024
    Date of Event
    May 11, 2022
    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
    CO, US
    Reporter Occupation
    501

    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. VISUAL EVALUATION SHOWED THE LOCKING KEY AND PINCH GUARD ARE DISSEMBLED FROM THE DEVICE. THE WELD OF PIN THAT HOLD IT TOGETHER HAS BROKEN OFF. DEVICE FUNCTIONING COULD NOT BE PERFORMED DUE TO THE DAMAGED OF THE DEVICE. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO USER-APPLIED MECHANICAL FORCES DURING USE.

    Description of Event or Problem · 0

    ON 5/12/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN 5030-000 LAG SCREW INSERTER PIN POPPED OUT DURING THE PROCEDURE, NOT ALLOWING THE SURGEON TO PROPERLY ENGAGE THE LAG SCREW LOCKING TOOL. UPON REMOVAL O THE 1192-120 LAG SCREW, IT WAS DETERMINED THAT IT WAS MISSING THE LOCKING RING. SURGEON MADE SURE IT HAD NOT BROKEN INSIDE THE PATIENT AND CONFIRMED IT DID NOT; THEREFORE DETERMINED IT WAS MISSING UPON OPENING PACKAGE. A SECOND LAG SCREW WAS USED AND CASE WAS COMPLETED WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING AN INTERTROCHANTERIC FRACTURE PROCEDURE ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550994 GALILEO® LAG SCREW INSERTER MANUAL INSTR, GENERAL SURGICAL HSB ARTHREX, INC. GALILEO® LAG SCREW INSERTER 212668 00848665036244

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown