BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO OSCILLATING SAW

    MDR report key: 2140624 · Received June 17, 2011

    Report

    Report Number
    1811755-2011-02196
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    July 30, 2010
    Report Date
    July 30, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR SERVICE AND EVAL. DURING THE INVESTIGATION AN OVERHEATING CONDITION WAS FOUND. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS INTERNAL CORROSION IN THE FRONT HOUSING. THE CORROSION LIKELY SEIZED THE BEARINGS AND PREVENTED THE DRIVE TRAIN FROM WORKING.

    Description of Event or Problem · 1

    THE HANDPIECE WAS RETURNED TO THE MANUFACTURER FOR SERVICE, AND DURING THE QUALITY INVESTIGATION THE DEVICE BEGAN OVERHEATING. THERE WAS NO SURGICAL OR MEDICAL PROCEDURE INVOLVED AT THE TIME, SO NO PT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK