BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE

    MDR report key: 2090248 · Received April 19, 2011

    Report

    Report Number
    1811755-2011-01321
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 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
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS REC'D AT THE MFR FOR EVAL, BUT BASED ON THE INVESTIGATION DETAILS, THE REPORTED CONDITION OF THE DEVICE OVERHEATING AND SMOKING DURING USAGE COULD NOT BE DUPLICATED. SVC REPLACED THE BACKBRACE, FLANGE NUTS, AND OTHER COMPONENTS AS SIGNS OF THIRD PARTY PARTS WERE FOUND. THE DEVICE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE BEGAN TO OVERHEAT AND SMOKE DURING A PROCEDURE WHERE THE ACCOUNT WAS REAMING FEMUR. THE PROCEDURE WAS CONTINUED WITH ANOTHER DEVICE. 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