BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE SUMEX DRILL

    MDR report key: 2771426 · Received September 28, 2012

    Report

    Report Number
    1811755-2012-03706
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    September 3, 2012
    Report Date
    September 3, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    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 END OF MOTOR WAS WORN AND THE COIL WAS BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING AT THE MFR, THE DEVICE DISPLAYED A BIAS CURRENT ERROR. THERE WAS O PT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ALLEGED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK