BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL DRILL

    MDR report key: 2241685 · Received September 2, 2011

    Report

    Report Number
    1811755-2011-03203
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 9, 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 DRILL WAS RECEIVED BY THE MFR AND THE COMPLAINT WAS CONFIRMED. INTERNAL COMPONENTS WERE EVALUATED AND EXTENSIVE CORROSION WAS DISCOVERED WITHIN THE MOTOR ASSEMBLY. THE PRESENCE OF CORROSION CAN LEAD TO INCREASED FRICTION BETWEEN THE ROTATING COMPONENTS, RESULTING IN HEAT BEING GENERATED. THE ROTOR AND MOTOR ASSEMBLIES WERE REPLACED DUE TO CORROSION AND HEAT DAMAGE, ADDITIONAL PREVENTATIVE MAINTENANCE WAS ALSO PERFORMED. THE DRILL WAS REPAIRED AND RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HEATED UP. THERE WAS NO REPORT OF ANY ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION. CUSTOMER COULD PROVIDE NO FURTHER EVENT DETAIL.

    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