BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO SAGITTAL SAW

    MDR report key: 2161756 · Received May 19, 2011

    Report

    Report Number
    1811755-2011-01805
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FAILURE ANALYSIS THE CUSTOMER'S COMPLAINT WAS CONFIRMED; THE DEVICE RAN ON ITS OWN WITHOUT ACTIVATION DURING PERFORMANCE TESTING. VISUAL ANALYSIS REVEALED WORN/DAMAGED PRESS PLUG AND MOTOR. THE ROTOR AND BEARINGS WERE CORRODED. THE DAMAGED PARTS WERE REPLACED AND THE DEVICE WAS REPAIRED, CLEANED LUBED, ADJUSTED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE MICRO SAGITTAL SAW WAS SENT IN FOR ANALYSIS BECAUSE, IT WOULD NOT TURN OFF EVEN WHEN IT WAS NOT BEING ACTIVATED. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO SAGITTAL SAW ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK