BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0/4.0MM HEADLESS CANNULATED SCREW DRIVER BIT

    MDR report key: 11398518 · Received March 2, 2021

    Report

    Report Number
    11398518
    Event Type
    Malfunction
    Date Received
    March 2, 2021
    Date of Event
    January 26, 2021
    Report Date
    February 23, 2021
    Manufacturer
    TRILLIANT SURGICAL, LTD.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A TRILLIAN SURGICAL LTD 3.0/4.0MM HEADLESS CANNULATED SCREW DRIVER BIT CAME OFF FROM THE ORTHOPEDIC BONE SCREW WHEN PLACING IT ON A PATIENT. ATTEMPTS TO REMOVE THE 3.0/4.0MM HEADLESS CANNULATED SCREW DRIVER BIT WITH A PICK AND THEN WITH IRRIGATION WHERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297717 3.0/4.0MM HEADLESS CANNULATED SCREW DRIVER BIT SCREW, FIXATION, BONE HWC TRILLIANT SURGICAL, LTD. TSL007083

    Patients

    Seq Age Sex Outcome Treatment
    1 14600 DA