BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIDAS REX HIGH SPEED NEUROSURGICAL DRILL

    MDR report key: 1813736 · Received August 19, 2010

    Report

    Report Number
    MW5017182
    Event Type
    Injury
    Date Received
    August 19, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 19, 2010
    Manufacturer
    MEDTRONIC NEUROLOGIC TECHNOLOGIES
    Product Code
    HBE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE DRILLING OFF THE LAMINA OF L5 ON THE LEFT SIDE, THE MIDAS REX DRILL CAME APART IN THE HANDS OF THE NEUROSURGEON, EXPOSING THE ENTIRE SET UP TO THE INTERIOR OF THE TOOL - WHICH IS NOT STERILE - A POTENTIALLY CONTAMINATED SPACE, NAMELY THE AREA BETWEEN THE OUTSIDE OF THE MIDAS TOOL AND THE INNER WORKING CHAMBER AS THE TOOL ITSELF CAME APART. THAT WAS IMMEDIATELY DISCARDED. GLOVES WERE CHANGED. THE WOUND WAS IRRIGATED WITH A FULL LITER OF WARM SALINE WITH 1 GRAM OF ANCEF. COMPLICATION: MIDAS REX TOOL CAME APART EXPOSING THE INTERIOR OF THE TOOL WHICH IS NOT STERILE. INFECTIOUS DISEASE CONSULT, PRESCRIBED TYPICAL 2 DOSES IV ANCEF PLUS ADDITIONAL ANTIBIOTICS FOR THIS PT R/T THIS INCIDENT: VANCOMYCIN - NEEDS LEVELS PERIODICALLY-, ROCEPHIN, AND FLAGYL, ALL IV. PERIPHERALLY-INSERTED CENTRAL CATHETER PLACED TO FACILITATE DELIVERY OF ALL THE IV ANTIBIOTICS AS WELL AS FREQUENT BLOOD DRAWS TO MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIDAS REX HIGH SPEED NEUROSURGICAL DRILL NONE HBE MEDTRONIC NEUROLOGIC TECHNOLOGIES C4821-D6AS14

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| S