BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE TRIGGER ROTARY

    MDR report key: 2082111 · Received April 26, 2011

    Report

    Report Number
    1811755-2011-01436
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 8, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR SERVICE AND EVALUATION. DURING THE INVESTIGATION, A RUN-ON CONDITION WAS FOUND AND THEN REPORTED. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS PROBLEMS WITH THE MOTOR AND FET COMPUTER CHIP. THOSE PARTS WERE EACH REPLACED ALONG WITH OTHER COMPONENTS. SERVICE REPAIRED AND RETURNED THE DEVICE TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE HANDPIECE WAS RETURNED TO THE MANUFACTURER FOR SERVICE, AND DURING THE INVESTIGATION, THE DEVICE CONTINUED TO RUN ON ITS OWN. THERE WAS NO PATIENT INVOLVEMENT OR ANY ADVERSE CONSEQUENCES DUE TO THIS REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE TRIGGER ROTARY KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK