BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO SAGITTAL SAW

    MDR report key: 2241625 · Received September 2, 2011

    Report

    Report Number
    1811755-2011-03269
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 11, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE OVERHEATING DESCRIBED WAS ATTRIBUTED TO THE DAMAGED BEARINGS AND CORRODED SOCKETS WHICH WERE IDENTIFIED AS THE PROBABLE CAUSE OF THE DEVICE RUNNING ON ITS OWN WITHOUT ACTIVATION DURING PERFORMANCE TESTING.

    Description of Event or Problem · 1

    THE MICRO SAGITTAL SAW WAS SENT FOR SERVICE AND IT OVERHEATED AND RAN ON ITS OWN WITHOUT ACTIVATION DURING PERFORMANCE TESTING. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK