BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL DRILL

    MDR report key: 1813027 · Received August 12, 2010

    Report

    Report Number
    1811755-2010-00932
    Event Type
    Malfunction
    Date Received
    August 12, 2010
    Date of Event
    July 28, 2009
    Report Date
    July 28, 2009
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL WAS RECEIVED BY THE MANUFACTURER AND THE COMPLAINT WAS CONFIRMED. INTERNAL COMPONENTS WERE EVALUATED AND THE MOTOR ASSEMBLY WAS FOUND TO BE CORRODED. MOTOR CORROSION WILL CREATE FRICTION WITHIN THE ROTOR, AND GENERATE HEAT. THE MOTOR ASSEMBLY WAS REPLACED AND THE DEVICE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE DEVICE EVALUATION CONDUCTED AT THE MANUFACTURER, THE DRILL HEATED UP. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, SO THERE WAS NO PATIENT INVOLVEMENT. NO USER INJURY WAS REPORTED, AND NO OTHER ADVERSE CONSEQUENCES WERE ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL DRILL DRILLS, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INC ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK