BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDAS REX MR8

    MDR report key: 13839074 · Received March 21, 2022

    Report

    Report Number
    13839074
    Event Type
    Malfunction
    Date Received
    March 21, 2022
    Date of Event
    March 10, 2022
    Report Date
    March 14, 2022
    Manufacturer
    MEDTRONIC POWERED SURGICAL SOLUTIONS
    Product Code
    HBC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS BROUGHT FROM THE ED (EMERGENCY DEPARTMENT) FOR AN EMERGENCY CRANIOTOMY FOR EVACUATION OF EPIDURAL HEMATOMA, AND WHEN THE SURGEON WENT TO USE THE MIDAS REX DRILL, THE HANDPIECE DID NOT WORK. IT WAS "SET DRILL MIDAS REX MR8 ELECTRIC TOUCH-008, MAIN ORTHO/NEURO ". OBSERVED BENT PINS INSIDE COUPLING. A REPLACEMENT MIDAS REX DRILL WAS IMMEDIATELY RETRIEVED, OPENED, AND USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515331 MIDAS REX MR8 MOTOR, DRILL, ELECTRIC HBC MEDTRONIC POWERED SURGICAL SOLUTIONS MR8

    Patients

    Seq Age Sex Outcome Treatment
    1 1095 DA Unknown