BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UHT DRILL - EUROPEAN

    MDR report key: 2082100 · Received April 26, 2011

    Report

    Report Number
    1811755-2011-01437
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL WAS RECEIVED BY THE U.S MANUFACTURER AND THE COMPLAINT WAS CONFIRMED. INTERNAL COMPONENTS WERE EVALUATED AND DAMAGE TO THE MOTOR ASSEMBLY, ROTOR ASSEMBLY, AND BEARINGS WERE DISCOVERED. IT IS UNKNOWN HOW THE DAMAGE OCCURRED. THE MOTOR ASSEMBLY, ROTOR ASSEMBLY AND BEARINGS WERE REPLACED, AND THE DRILL WAS RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING NEUROSURGERY, A DRILL AND ASSOCIATED DRILL ATTACHMENT HEATED UP AND SMOKE WAS OBSERVED COMING FROM THE DEVICE. BACKUP EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE, CAUSING A 15 MINUTE DELAY WHICH DID NOT ADVERSELY AFFECT THE PATIENT OR SURGICAL OUTCOME. NO PATIENT OR USER INJURY WAS REPORTED, AND NO OTHER ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UHT DRILL - EUROPEAN HBE STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK FIXED DURAGUARD, (B)(4), 16MM