BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT ATTACHMENT PERFORATOR DRIVER LEGEND AD01

    MDR report key: 476928 · Received August 5, 2003

    Report

    Report Number
    1625507-2003-00146
    Event Type
    Malfunction
    Date Received
    August 5, 2003
    Report Date
    March 12, 2003
    Manufacturer
    MEDTRONIC MIDAS REX
    Product Code
    HBB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DURING CRANIOTOMY, THE MOTOR STOPPED AND WOULD NOT RESTART EVEN WITH KICK START ATTEMPT. THE MOTOR WAS BEING USED WITH A LEGEND PERFORATOR. SOUNDS LIKE AIR IS GOING THROUGH, BUT MOTOR WOULD NOT SPIN. NO PT IMPACT OR SIGNIFICANT DELAYS EXPERIENCED. THE MOTOR WAS BEING USED WITH A LEGEND PERFORATOR. BACK UP UNITS WERE AVAILABLE TO COMPLETE THE PROCEDURE. IN 2003, ADDITIONAL INFO WAS IDENTIFIED RELATED TO THIS COMPLAINT. ACCORDING TO THIS REPORT FILED BY THE MANUFACTURER OF THE PERFORATOR DISSECTING TOOL, "DURING A CRANIOTOMY FOR A BRAIN TUMOR, THE DISPOSABLE PERFORATOR WAS USED BY THE CUSTOMER WITH A NEW (MIDAS REX) CRANIOTOME. ON THE FOURTH BURR HOLE, THE DRILL STOPPED SPINNING AND BECAME STUCK IN BONE. ANOTHER PERFORATOR WAS USED TO DRILL AND DISLODGE THE DEVICE. IT IS NOT KNOWN IF THE DIFFICULTY WAS CAUSED BY THE FAILURE OF THE PERFORATOR [DISSECTING TOOL], THE [MIDAS REX] CRANIOTOME, OR BY SOME OTHER VARIABLE. IT IS REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES TO THE PT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRAIGHT ATTACHMENT PERFORATOR DRIVER LEGEND AD01 PNEUMATIC SURG DRILL ATTACHMENT LEGEND HBB MEDTRONIC MIDAS REX NA *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention