BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO SAGITTAL SAW

    MDR report key: 2033744 · Received March 23, 2011

    Report

    Report Number
    1811755-2011-00923
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    February 26, 2011
    Report Date
    February 26, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE QUALITY INVESTIGATION TESTING, THE CUSTOMER'S CONCERN WAS CONFIRMED; THE DEVICE WAS RUNNING WITHOUT ACTIVATION. FURTHER INVESTIGATION REVEALED A BROKEN BEARING AND CORROSION DAMAGE TO THE MID SPEED MOTOR AND THE PRESS PLUG. THE CORRODED MID SPEED MOTOR WAS IDENTIFIED AS THE PRIMARY CAUSE OF THE FAILURE. THE FAULTY PARTS WERE REPLACED AND THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    A STRYKER MICRO SAGITTAL SAW WAS SENT IN FOR REPAIR BECAUSE, IT WAS RUNNING ON ITS OWN. THE EVENT WAS DISCOVERED DURING ROUTINE MAINTENANCE TESTING. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO SAGITTAL SAW BONE CUTTING INSTRUMENT AND ACCESSORIES HBE STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK