BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL DRILL

    MDR report key: 2233172 · Received July 22, 2011

    Report

    Report Number
    1811755-2011-02630
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED AND THE REPORTED FAILURE BY THE CUSTOMER WAS CONFIRMED. UPON VISUAL INSPECTION THE BEARINGS ON THE ROTOR ASSEMBLY WERE FOUND TO HAVE FAILED AS A RESULT OF CORROSION DAMAGE. THE BEARINGS FUNCTION TO REDUCE FRICTION DURING ROTOR ROTATION IN THE MOTOR COILS; CORROSION BUILDUP CAN PREVENT THE BEARINGS FROM REDUCING THE FRICTION AND CAN RESULT IN HEAT GENERATION. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRILL WAS OVERHEATING DURING A PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK