BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE SUMEX DRILL

    MDR report key: 2123318 · Received June 8, 2011

    Report

    Report Number
    1811755-2011-02084
    Event Type
    Malfunction
    Date Received
    June 8, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 11, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AND THE REPORTED FAILURE WAS CONFIRMED. THE ROTOR ASSEMBLY WAS FOUND TO BE CORRODED. THE DHR REVIEW INDICATED THE DEVICE PASSED ALL TESTING AND INSPECTIONS AS REQUIRED AT THE TIME OF MANUFACTURE; THERE WERE NO RELEVANT NON-CONFORMANCES, ALERTS, DEVIATIONS, OR REWORK. THERE WERE NO RELEVANT DESIGN/PROCESS CHANGES RELATED TO THIS CONFIRMED FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRILL'S HANDLE WAS HEATING UP. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK