BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER CORE CRANI/SPINE DRILL

    MDR report key: 3288851 · Received July 16, 2013

    Report

    Report Number
    3288851
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    July 13, 2013
    Report Date
    July 16, 2013
    Manufacturer
    STRYKERSPINE
    Product Code
    HBF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN WAS USING THE STRYKER CRANITOME DRILL. THE DRILL WAS NOTICED TO BE GETTING VERY HOT IN THE HAND OF THE SURGEON (THE PHYSICIAN HAS HAD THIS HAPPEN BEFORE, SO HE QUICKLY HANDED THE DRILL OFF AND OBTAINED A SECOND DRILL). THE SECOND PROBLEM WITH THE DRILL IS THAT EVERYONE REMOVES CORD FROM DRILL CONSOLE. THE HAND PIECE PLUGS IN EASILY BUT ALMOST EVERYONE HAS TO "YANK" EXTREMELY HARD TO GET HAND PIECE OUT. IT IS NOT A PUSH PULL OUT THIS DOES NOT SEEM SAFE AND ALWAYS AT END OF CASE.======================MANUFACTURER RESPONSE FOR STRYKER CRANITOME DRILL, STRYKER CORE CRANI/SPINE DRILL (PER SITE REPORTER).======================WILL SEND FOLLOW-UP INFORMATION, STRYKER HAS BEEN INCREDIBLY RESPONSIVE TO THE FOLLOW-UP CONCERNING THE PRIOR ALERTS THAT OUR INSTITUTION HAS COMPLETED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?USING THE DRILL DURING A NEUROSURGERY PROCEDURE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330534 STRYKER CORE CRANI/SPINE DRILL DRILL HBF STRYKERSPINE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * SEE BELOW