BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 7 DUAL TRIGGER ROTARY

    MDR report key: 4862046 · Received June 23, 2015

    Report

    Report Number
    0001811755-2015-02284
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    May 27, 2015
    Report Date
    May 27, 2015
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS CONFIRMED. SERVICE EVALUATION FOUND THAT THE BOTTOM TRIGGER WOULD STAY IN THE RUN POSITION CAUSING DEVICE RUN-ON, DUE TO CORROSION. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    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.

    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 PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS 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 PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406130 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