BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 7 DUAL TRIGGER ROTARY

    MDR report key: 3192143 · Received June 27, 2013

    Report

    Report Number
    0001811755-2013-01474
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IS ONGOING; ADDITIONAL INFORMATION MAY BE SUBMITTED ONCE THE RESULTS ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF RUN-ON WAS CONFIRMED. DURING FUNCTIONAL TESTING IT WAS OBSERVED THAT THE FORWARD TRIGGER STICKS AND THE DEVICE CONTINUED TO RUN WHEN LET GO, BUT THERE WERE NO FUNCTIONAL ISSUES WITH THE TRIGGER ASSEMBLY. THE STAFF MECHANICAL ENGINEER IN FAILURE ANALYSIS, (B)(4), DETERMINED AN E-BOX FAILURE AS THE PRIMARY FAILURE. THE E-BOX CONTROLS THE ELECTRONICS OF THE DEVICE, AND DAMAGE TO THE ELECTRONIC COMPONENTS WILL CAUSE IT TO NOT FUNCTION PROPERLY IF AT ALL. THIS FAILURE MAY CAUSE RUN-ON OR REDUCED PERFORMANCE OR EFFICIENCY. CORROSION WAS ALSO FOUND INSIDE THE DEVICE, WHICH MAY HAVE CONTRIBUTED TO THE EVENTS AS WELL.

    Description of Event or Problem · 1

    THE SYSTEM 7 DUAL TRIGGER ROTARY WAS RETURNED TO STRYKER INSTRUMENTS FOR SERVICE, AND DURING FUNCTIONAL EVALUATION IT WAS NOTED THAT THE DEVICE CONTINUED TO RUN AFTER LETTING GO OF THE FORWARD TRIGGER. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 1

    THE SYSTEM 7 DUAL TRIGGER ROTARY WAS RETURNED TO STRYKER INSTRUMENTS FOR SERVICE, AND DURING FUNCTIONAL EVALUATION IT WAS NOTED THAT THE DEVICE CONTINUED TO RUN AFTER LETTING GO OF THE FORWARD TRIGGER. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293487 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