BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 PRECISION HANDPIECE

    MDR report key: 3853094 · Received June 6, 2014

    Report

    Report Number
    0001811755-2014-02074
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED. FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE REPORTED RUN-ON WAS CONFIRMED BY A MANUFACTURER REPAIR TECHNICIAN THROUGH FUNCTIONAL EVALUATION. UPON DISASSEMBLY, A FAILED E-BOX WAS FOUND, WHICH CAN LEAD TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING EQUIPMENT TESTING CONDUCTED BY A MANUFACTURER FIELD SERVICE TECHNICIAN AT THE USER FACILITY THE DEVICE RAN WITHOUT USER ACTIVATION AFTER THE TRIGGER WAS RELEASED. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING EQUIPMENT TESTING CONDUCTED BY A MANUFACTURER FIELD SERVICE TECHNICIAN AT THE USER FACILITY, THE DEVICE RAN WITHOUT USER ACTIVATION AFTER THE TRIGGER WAS RELEASED. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332999 SYSTEM 6 PRECISION HANDPIECE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1