BEUDAMED
    FDA Adverse Event Summary report: N

    CORE SUMEX

    MDR report key: 3181530 · Received June 11, 2013

    Report

    Report Number
    3181530
    Date Received
    June 11, 2013
    Date of Event
    June 9, 2013
    Report Date
    June 11, 2013
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    HBE
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    ON AT LEAST THREE OCCASIONS WITHIN ONE WEEK, WE RECEIVED REPORT OF EVENTS FROM SURGEONS WHO WERE USING THE STRYKER CORE SUMEX CRANIAL DRILL. THE SURGEONS REPORTED THAT THE HAND PIECE ON THE DRILL BECAME VERY HOT, THAT THE DRILL VIBRATED, AND THAT THE BIT DID NOT CUT STRAIGHT. EACH TIME, THE DRILL REQUIRED REMOVAL FROM THE SURGICAL FIELD AND A SUBSTITUTE DRILL WAS USED TO COMPLETE THE PROCEDURE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?THE ORIGINAL INTENDED PURPOSE WAS TO USE THE DRILL TO MAKE HOLES IN THE PATIENT'S SKULL AT THE BEGINNING OF THE OPERATING ROOM PROCEDURE (USED EXCLUSIVELY IN NEUROSURGERY).DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263831 CORE SUMEX DRILL HBE STRYKER INSTRUMENTS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR NO OTHER DEVICES INVOLVED - THIS PROBLEM WAS| SURGICAL CRANIAL DRILL. NO OTHER EQUIPMENT| IMPACTED THIS EQUIPMENT'S PERFORMANCE.| EXPERIENCED BY THE SURGEON OPERATOR OF THE