BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM CANNULATED SCREW DRIVER

    MDR report key: 6529869 · Received April 28, 2017

    Report

    Report Number
    3007420745-2017-00006
    Event Type
    Malfunction
    Date Received
    April 28, 2017
    Date of Event
    March 17, 2017
    Report Date
    April 28, 2017
    Manufacturer
    TRILLIANT SURGICAL, LTD
    Product Code
    HWC
    PMA / PMN Number
    K112737
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING A BUNIONECTOMY ON A (B)(6) FEMALE, THE DOCTOR EXPERIENCED A 2.4MM HEADLESS DRIVER BREAK. THE DOCTOR FULLY PRE DRILLED AND PROX DRILLED AND HAD ALMOST FULLY INSERTED THE 202-24-024 SCREW INTO THE PATIENT WHEN DURING THE LAST 5 TURNS OR SO, THE DRIVER BROKE. FLOURO WAS UTILIZED TO CLEAN OUT FRAGMENTS FROM THE SURGICAL SITE. THE DOCTOR THEN USED THE 2.4MM HEADLESS REMOVAL BIT TO COMPLETE THE CASE. AFTER THE PATIENT WAS CLOSED UP AND FLOURO WAS AGAIN UTILIZED, THE DOCTOR NOTICED THERE WERE DRIVER FRAGMENTS REMAINING IN THE PATIENT. THE 202-24-024 SCREW REMAINS IN THE PATIENT AND THE 2.4 HEADLESS REMOVAL BIT WAS KEPT AS IT WAS FINE TO USE FOR OTHER CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313051 2.4MM CANNULATED SCREW DRIVER SCREW DRIVER HWC TRILLIANT SURGICAL, LTD 19591

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR