BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO LAG SCREW, RIGHT, Ø10.5MMX90MM

    MDR report key: 19831052 · Received July 25, 2024

    Report

    Report Number
    1220246-2024-06920
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    April 1, 2024
    Report Date
    July 25, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665015836
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT ALLEGATION WAS CONFIRMED. ONE UNPACKAGED 1099-090 BATCH 212625 WAS RECEIVED FOR INVESTIGATION. THE DEVICE ARRIVED WITH THE PART NUMBER 0857-100 BATCH 221019 STUCK INSIDE. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DEVICE ARRIVED STUCK INSIDE THE PART NUMBER 0857-100 BATCH 221019. UPON VISUAL INSPECTION, SCRATCHES WERE NOTED AROUND THE OUTSIDE DIAMETER. ADDITIONALLY, IT WAS OBSERVED THAT THE DEVICE'S THREAD HAD NICKS AND WAS BENT. THE MOST LIKELY CAUSE(S) OF THE REPORTED FAILURE ARE USER ERROR, MISALIGNED INSERTION, OR EXCESSIVE FORCE DURING USE.

    Description of Event or Problem · 0

    ON 04/01/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS(B)(4) THAT AN 0857-100 GALILEO EXTRACTION TOOL WAS DAMAGED DURING THE CASE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM. ON 07/10/2024, DURING DEVICE EVALUATION OF THE RETURNED DEVICE, IT WAS FOUND THAT THE 0857-100 WAS STUCK INSIDE A 1099-090 GALILEO LAG SCREW, RIGHT, Ø10.5MMX90MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253841 GALILEO LAG SCREW, RIGHT, Ø10.5MMX90MM INTRAMED FIXATN ROD AND ACCESS HSB ARTHREX, INC. GALILEO LAG SCREW, RIGHT, Ø10.5MMX90MM 212625 00848665015836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown