BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO SAGITTAL SAW

    MDR report key: 1894704 · Received November 5, 2010

    Report

    Report Number
    1811755-2010-01598
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 15, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MFR FOR EVAL, 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, WHICH WAS REPLACED ALONG WITH OTHER COMPONENTS. SERVICE DID A CLEAN, LUBE, AND ADJUST TO THE DEVICE, AND IT WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A FIELD SERVICE TECH THAT THE HANDPIECE HAD INTERMITTENT RUN-ON DURING A ROUTINE MAINTENANCE VISIT AND IN A NON-STERILE ENVIRONMENT. THIS DID NOT OCCUR DURING A SURGICAL PROCEDURE. THERE WAS 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 SAGITTAL SAW SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTAC HBE STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK