BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE

    MDR report key: 2082516 · Received April 28, 2011

    Report

    Report Number
    1811755-2011-01445
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MFR FOR EVAL, AND THE REPORTED CONDITION OF THE DEVICE SMOKING WAS DUPLICATED. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS A THIRD PARTY ASIC (MOTOR CONTROLLER). THE HANDPIECE SHOWED SIGNS OF TAMPERING, UNAUTHORIZED REPAIRS, AND OTHER THIRD PARTY COMPONENTS. ALL THIRD PARTY AND FAILED COMPONENTS WERE REPLACED. SERVICE REPAIRED AND RETURNED THE DEVICE TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE BEGAN SMOKING WHEN CONNECTED TO THE BATTERY DURING A SET UP FOR A TOTAL KNEE ARTHROPLASTY CASE. THERE WAS NO PT INVOLVEMENT. BACKUP EQUIPMENT WAS USED TO COMPLETE THE PLANNED PROCEDURE. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED, AND 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