BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE MICRO DRILL

    MDR report key: 2121127 · Received May 4, 2011

    Report

    Report Number
    1811755-2011-01583
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    April 7, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE TECHNICIAN CONFIRMED THE EVENT AND DETERMINED THE PRIMARY CAUSE WAS FAILURE OF THE MOTOR CARTRIDGE DUE TO CORROSION. THIS CORROSION MAY CAUSE FRICTION LEADING TO THE HEATING DESCRIBED BY THE CUSTOMER. 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 SURGERY. THEY USED THE SAME HANDPIECE 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 MICRO DRILL ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK