BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 5 SAGITTAL SAW

    MDR report key: 2140625 · Received June 17, 2011

    Report

    Report Number
    1811755-2011-02194
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 27, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    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 MANUFACTURER FOR EVAL, AND THE SERVICE TECHNICIAN CONFIRMED THE REPORTED EVENT. THE SCREW CAN LOOSEN THROUGH STANDARD CLEANING AND AUTOCLAVING CYCLES. WHEN A HANDPIECE IS PUT INTO AN AUTOCLAVE THE METALS WITHIN THE HANDPIECE EXPAND AND CONTRACT, THUS POTENTIALLY CAUSING THE SCREW TO LOOSEN OVER TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SCREW FELL OUT OF THE HANDPIECE. 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 SYSTEM 5 SAGITTAL SAW KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK