BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 SAGITTAL SAW

    MDR report key: 3902335 · Received June 30, 2014

    Report

    Report Number
    0001811755-2014-02323
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 3, 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

    THE REPORTED EVENT WAS DUPLICATED. THROUGH INSPECTION, THE SERVICE TECHNICIAN FOUND THE TRIGGER TO BE BROKEN AT THE SCREW BOSS AND MISSING FROM THE HANDPIECE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE USER FACILITY THAT THE TRIGGER OF THE SYSTEM 6 SAGITTAL SAW WAS BROKEN. THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379403 SYSTEM 6 SAGITTAL SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1