BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 SAGITTAL SAW

    MDR report key: 3900240 · Received June 27, 2014

    Report

    Report Number
    0001811755-2014-02298
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 3, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THROUGH INITIAL INSPECTION, THE TECHNICIAN FOUND AN OIL LIKE SUBSTANCE LEAKING FORM THE BLADE MOUNT. A SUBSTANCE INSIDE THE HANDPIECE OR LEAKING FROM THE HANDPIECE COULD HAVE BEEN CAUSED BY IMPROPER CLEANING AND STERILIZATION PRACTICES AT THE ACCOUNT SITE, BUT THIS WAS NOT DIRECTLY ABLE TO BE CONFIRMED. UPON VISUAL INSPECTION, THE DEVICE WAS ALSO FOUND TO HAVE A WORN ECCENTRIC BEARING, A LOOSE DRIVE LINK ON THE BLADE MOUNT BASE, AND WORN FRONT CAP II CASTLE FEATURES. THE DEVICE WAS REPAIRED AND RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A PROCEDURE, THE SYSTEM 6 SAGITTAL SAW WAS FOUND TO BE SPITTING OIL. IT WAS REPORTED THAT THERE WAS NO ASSOCIATED PROCEDURE. NO PATIENT INVOLVEMENT, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377922 SYSTEM 6 SAGITTAL SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1