BEUDAMED
    FDA Adverse Event Summary report: N

    STRYKER INSTRUMENTS

    MDR report key: 449247 · Received March 18, 2003

    Report

    Report Number
    MW1027929
    Date Received
    March 18, 2003
    Date of Event
    March 17, 2003
    Report Date
    March 18, 2003
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    GEI
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM MFR 5/22/03: TEST SUMMARY READS: THE TEST WAS COMPLETED AS SPECIFIED IN THE TEST PROCEDURE WITH BOTH BURS MEETING THE MINIMUM PERFORMANCE REQUIRED. MANUAL TESTING WAS PERFORMED AS DETAILED ABOVE, THE BURS DID NOT EXHIBIT EXCESSIVE HEAD DETERIORATION, SHELL REMOVAL OF COATING, EXCESSIVE LOSS OF DIAMOND COATING OR FATIGUE. THERE WERE NO BREAKAGES. THERE WAS NOTICEABLE DISCOLORATION HOWEVER THIS MAY BE DUE TO THE EXTENDED PERIOD CUTTING WITHOUT IRRIGATION.

    Description of Event or Problem · 1

    DIAMOND COATING CAME OFF DRILL BIT. CAME OFF IN PT BUT WAS ABLE TO BE RETRIEVED BY SURGEON. NO ADVERSE EFFECT TO PT. SAME PROBLEM OCCURRED TWICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER INSTRUMENTS DIAMOND COATED DRILL BIT GEI STRYKER INSTRUMENTS * 021024478M

    Patients

    Seq Age Sex Outcome Treatment
    1 *