BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2121128 · Received May 4, 2011

    Report

    Report Number
    1811755-2011-01581
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 11, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY THE MANUFACTURER AND THE HANDPIECE EXCEEDED THE MAXIMUM ALLOWED TEMPERATURE RISE AND HAD EXCESSIVE NOISE COMING FROM THE MOTOR. THE CONTACT PINS WERE BURNT AND THERE WAS INSUFFICIENT LUBE IN THE BEARINGS ON THE ROTOR AND DRIVESHAFT ASSEMBLIES. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT WAS HEATING UP DURING A WISDOM TOOTH REMOVAL. ANOTHER DRILL WAS PULLED TO COMPLETE THE PROCEDURE. THERE WAS NO MEDICAL INTERVENTION REQUIRED AND NO DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE IMPACTION DRILL ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK