BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO SAGITTAL SAW

    MDR report key: 1924654 · Received December 9, 2010

    Report

    Report Number
    1811755-2010-01991
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    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 MFR FOR SERVICE, AND A CONDITION OF RUN-ON WAS FOUND. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS PROBLEMS WITH THE MOTOR, PRESS PLUGS, SPHERICAL BEARING, AND BLADE MOUNT. THOSE PARTS WERE REPLACED ALONG WITH THE HOUSING. SERVICE REPAIRED AND RETURNED THE DEVICE TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE HANDPIECE WAS RETURNED TO THE MFR FOR SERVICE, AND DURING THE INVESTIGATION A RUN-ON CONDITION WAS FOUND. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE. THERE WAS NO PT INVOLVEMENT OR ANY ADVERSE CONSEQUENCES 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 ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK