BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3030050 · Received March 27, 2013

    Report

    Report Number
    3030050
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 27, 2013
    Manufacturer
    ACUMED, LLC
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    WHILE FIXING A FRACTURED ELBOW, THE DOCTOR WAS DRILLING A SCREW HOLE AND THE DRILL BIT BROKE INSIDE THE ELBOW AND WAS IRRETRIEVABLE. EVENT WAS NOT PREVENTABLE. UNABLE TO RETRIEVE LOST PIECE OF BROKEN DRILL BIT AS IT BROKE INSIDE THE BONE. X-RAY TAKEN IN THE OR TO RECORD BROKEN DRILL TIPS LOCATION. X-RAY READ BY DOCTOR, STATED THAT A SCREW NOT ORIGINATING FROM ONE OF THE END PLATES WAS SEEN. HE WAS INFORMED THAT ALL SCREWS WERE ANCHORED TO THE PLATES AND IT WAS DETERMINED THAT THIS WAS THE BROKEN DRILL BIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125245 * PLATE, FIXATION, BONE HRS ACUMED, LLC 80-0627 *

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR