BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE

    MDR report key: 2140643 · Received June 17, 2011

    Report

    Report Number
    1811755-2011-02193
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR EVALUATION. BASED ON THE INVESTIGATION DETAILS THE REPORTED CONDITION WAS DUPLICATED. THE NUT 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 BACK NUT TO LOOSEN OVER TIME. THE DRIVE HOUSING AND BACK NUT WERE EACH UPGRADED ALONG WITH THE REPLACEMENT OF OTHER COMPONENTS IN THE HANDPIECE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE FELL APART EXPOSING INTERNAL COMPONENTS DURING A TOTAL KNEE PROCEDURE. ALL THE PARTS WERE LOCATED, AND NOTHING FELL INTO THE SITE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO MEDICAL INTERVENTION REQUIRED. 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 DUAL TRIGGER ROTARY HANDPIECE KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK