BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ES6 SINGLE TRIGGER ROTARY

    MDR report key: 3902334 · Received June 30, 2014

    Report

    Report Number
    0001811755-2014-02322
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS DUPLICATED. UPON DISASSEMBLY THE TECHNICIAN NOTED A FAILURE OF THE POTTED TRIGGER PCB ASSEMBLY.

    Description of Event or Problem · 1

    THE ES6 SINGLE TRIGGER ROTARY WAS RETURNED TO STRYKER INSTRUMENTS FOR SERVICE. DURING FUNCTIONAL TESTING BY A SERVICE TECHNICIAN, IT WAS FOUND THAT THE DEVICE CAUSED A BIAS CURRENT MESSAGE TO BE DISPLAYED ON THE CONSOLE, SIGNALING A CONDITION OCCURRED IN WHICH THE DEVICE HAS THE POTENTIAL TO RUN WITHOUT USER ACTIVATION. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378984 ES6 SINGLE TRIGGER ROTARY INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1