BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDAS REX

    MDR report key: 2544894 · Received April 20, 2012

    Report

    Report Number
    2544894
    Event Type
    Malfunction
    Date Received
    April 20, 2012
    Date of Event
    February 23, 2012
    Report Date
    February 27, 2012
    Manufacturer
    MEDTRONIC POWERED SURGICAL SOLUTIONS
    Product Code
    HBE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING THE CREATION OF A BONE FLAP WITH THE MIDAS REX SYSTEM, THE BLADE WHICH IS THE WORKING END OF THE MIDAS REX STOPPED CUTTING. IT WAS NOTED BY THE STAFF AND PHYSICIAN THAT THE END OF THE BLADE APPEARED TO HAVE BROKEN OFF. THE REMAINDER OF THE BONE FLAP WAS CREATED BY THE PHYSICIAN USING A KERRISON RONGEUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIDAS REX DRILL, SURGICAL, PNEUMATIC HBE MEDTRONIC POWERED SURGICAL SOLUTIONS F2/8TA23 0006044143

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR