BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL SAW

    MDR report key: 2160815 · Received June 30, 2011

    Report

    Report Number
    1811755-2011-02326
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 9, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MFR FOR EVAL, BUT BASED ON THE QA INVESTIGATION DETAILS THE REPORTED CONDITION OF THE DEVICE LEAKING OIL COULD NOT BE DUPLICATED. SERVICE REPLACED SOME COMPONENTS AS PART OF NORMAL PREVENTIVE MAINTENANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE WAS LEAKING OIL. THIS WAS NOT 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 SAGITTAL SAW KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK