BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE SUMEX DRILL

    MDR report key: 2903160 · Received November 26, 2012

    Report

    Report Number
    1811755-2012-04147
    Event Type
    Malfunction
    Date Received
    November 26, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    STRYKER INSTRUMENTS, INSTRUMENTS DIV.
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL COMPONENTS WERE EVALUATED WHICH REVEALED THAT THE ROTOR AND THE MOTOR ASSEMBLY WERE WORN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING BY THE MFR, THE DEVICE DISPLAYED A BIAS CURRENT ERROR WHEN CONNECTED TO THE CONSOLE, SIGNALING A CONDITION OCCURRED FROM WHICH THE DEVICE HAD THE POTENTIAL TO RUN WITHOUT USER ACTIVATION. THERE WAS NO PATIENT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE SUMEX DRILL ERL STRYKER INSTRUMENTS, INSTRUMENTS DIV.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK