BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDAS REX DRILL

    MDR report key: 1202799 · Received September 16, 2008

    Report

    Report Number
    1202799
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    August 18, 2008
    Report Date
    September 16, 2008
    Manufacturer
    MEDTRONIC MIDAS REX
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SCRUB NURSE NOTICED WHEN TESTING MIDAS REX THAT IT DID NOT SOUND RIGHT. THE SCRUB HANDED THE DRILL TO THE SURGEON, THEY AGAIN TESTED THE DRILL AND DECIDED NOT TO USE IT. THE SURGEON HANDED THE DRILL BACK TO THE SCRUB NURSE AND AT THIS TIME THE INSIDE OF THE DRILL BROKE AND FELL OUT ON THE FIELD BUT NOT NEAR THE SURGICAL WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIDAS REX DRILL DRILL, SURGICAL HTW MEDTRONIC MIDAS REX EM100A 89445-03

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR