BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 PRECISION HANDPIECE

    MDR report key: 2082095 · Received April 26, 2011

    Report

    Report Number
    1811755-2011-01414
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 28, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE CUSTOMER'S COMMENT WAS CONFIRMED. THE WARM HANDPIECE WAS DUE TO A MALFUNCTIONING E-BOX. THE DHR REVIEW INDICATED THE DEVICE PASSED ALL TESTING AND INSPECTIONS AS REQUIRED AT THE TIME OF MANUFACTURE; THERE WERE NO RELEVANT NON-CONFORMANCES, ALERTS, DEVIATIONS, OR REWORK. THERE WERE NO PREVIOUS REPAIRS RELEVANT TO THE CONFIRMED FAILURE BASED ON A REVIEW OF THE SERVICE HISTORY OF THIS DEVICE. THERE WERE NO RELEVANT NON-CONFORMANCES, ALERTS, DEVIATIONS, OR REWORK RELATED TO THIS CONFIRMED FAILURE. THERE WERE NO RELEVANT DESIGN/PROCESS CHANGES RELATED TO THIS CONFIRMED FAILURE. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDLE OF THE SAW WAS GETTING HOT DURING A CASE. A BACKUP WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO MEDICAL INTERVENTION REQUIRED AND NO DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 6 PRECISION HANDPIECE KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK