BEUDAMED
    FDA Adverse Event Other Summary report: N

    MIDAS REX LEGAND DRILL

    MDR report key: 557055 · Received November 11, 2004

    Report

    Report Number
    557055
    Event Type
    Other
    Date Received
    November 11, 2004
    Date of Event
    September 15, 2004
    Report Date
    November 11, 2004
    Manufacturer
    MEDTRONIC MIDAS REX
    Product Code
    HBE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BRAND NEW MEDTRONIC MIDAS DRILL WAS BEING USED DURING CRANIOTOMY.DRILL COULD NOT BE UNLOCKED TO CHANGE DRILL BIT, PER STAFF "FELT LIKE IT WAS FROZEN". EVENTUALLY DRILL WAS REMOVED FROM OPERATIVE FIELD AND REPLACED. WITH MUCH DISTRESS, FINALLY ABLE TO UNLOCK AND CHANGE BIT AFTER MULTIPLE ATTEMPTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIDAS REX LEGAND DRILL ORTHOPEDIC BONE DRILL HBE MEDTRONIC MIDAS REX * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *