BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U2 DRILL

    MDR report key: 2241638 · Received September 2, 2011

    Report

    Report Number
    1811755-2011-03204
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 5, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL WAS RECEIVED BY THE MANUFACTURER; HOWEVER THE COMPLAINT COULD NOT BE REPLICATED DUE TO THE HANDPIECE NOT FUNCTIONING. INTERNAL COMPONENTS WERE EVALUATED AND THE ROTOR AND MOTOR WERE CORRODED. THE MOTOR ASSEMBLY, ROTOR, AND BEARINGS WERE REPLACED AND THE DRILL WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING, THE DEVICE CONTINUED TO RUN WHEN IN SAFE MODE. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE. THERE WAS NO REPORT OF USER INJURY, OR OF ANY ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U2 DRILL ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK