BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3802308 · Received April 28, 2014

    Report

    Report Number
    3802308
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 28, 2014
    Manufacturer
    SYNTHES (USA) LLC
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    THE DRILL BIT BROKE OFF INSIDE THE PATIENT'S PELVIS. UNABLE TO RETRIEVE THE BROKEN PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253291 * BIT, DRILL HTW SYNTHES (USA) LLC * 5642004

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR