BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO OSCILLATING SAW

    MDR report key: 1841972 · Received August 24, 2010

    Report

    Report Number
    1811755-2010-01004
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 28, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 CONFIRMED. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS PROBLEMS WITH DEBRIS IN THE BEARINGS, WHICH WERE EACH REPLACED ALONG WITH THE MOTOR ASSEMBLY. THE ITEM WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE CONTINUED TO RUN ON ITS OWN DURING A SURGICAL PROCEDURE. THERE HAS BEEN NO REPORTED PATIENT OR USER INJURY, AND THE CASE WAS SUCCESSFULLY COMPLETED AS PLANNED WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO OSCILLATING SAW POWERED SIMPLE CRANIAL DRILLS, BURRS, TREPHINES, A HBE STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK