BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO OSCILLATING SAW

    MDR report key: 1931441 · Received December 8, 2010

    Report

    Report Number
    1811755-2010-01966
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MFR FOR SERVICE, AND A RUN-ON CONDITION WAS FOUND. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS A CORRODED MOTOR AND PROBLEMS WITH BEARINGS. THOSE PARTS WERE REPLACED ALONG WITH OTHER COMPONENTS. SERVICE REPAIRED AND RETURNED THE DEVICE TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE HANDPIECE WAS RETURNED TO THE MANUFACTURER FOR SERVICE, AND DURING THE INVESTIGATION, A RUN-ON CONDITION WAS FOUND. THIS DID NOT OCCUR DURING A SURGICAL PROCEDURE. THERE WAS NO PT INVOLVEMENT OR ANY ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK