BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 5 SINGLE TRIGGER ROTARY HANDPIECE

    MDR report key: 1853641 · Received September 29, 2010

    Report

    Report Number
    1811755-2010-01266
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 1, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AND AN INVESTIGATION IS ANTICIPATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE HANDPIECE WAS IN THE CENTRAL STERILE DEPARTMENT IT WAS LEAKING THROUGH THE HANDLE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 5 SINGLE TRIGGER ROTARY HANDPIECE INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK