BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 7 DUAL TRIGGER ROTARY

    MDR report key: 3080158 · Received April 26, 2013

    Report

    Report Number
    0001811755-2013-00906
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SYSTEM 7 DUAL TRIGGER ROTARY HANDPIECE WAS RETURNED TO STRYKER INSTRUMENTS FOR EVALUATION FOR RUNNING IN AN UNINTENDED DIRECTION; HANDPIECE WOULD NOT RUN IN FORWARD UNTIL REVERSE TRIGGER WAS PULLED. IT WAS ALSO FOUND THAT THE UNIT WOULD OSCILLATE ONLY WHEN THE FORWARD TRIGGER WAS PULLED. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182928 SYSTEM 7 DUAL TRIGGER ROTARY INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1