BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO SAGITTAL SAW

    MDR report key: 1842209 · Received August 24, 2010

    Report

    Report Number
    1811755-2010-01001
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 3, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR EVALUATION, AND THE REPORTED CONDITION OF THE DEVICE RUNNING ON ITS OWN WAS DUPLICATED. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS PROBLEMS WITH THE MOTOR, A WORN BEARING, AND THE SAG HEAD. THOSE PARTS WERE EACH REPLACED ALONG WITH OTHER COMPONENTS. SERVICE REPAIRED AND RETURNED THE DEVICE TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE CONTINUED TO RUN ON ITS OWN PRIOR TO THE START OF A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF ANY ADVERSE CONSEQUENCES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO SAGITTAL SAW SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTAC HBE STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK