BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 7 RECIP SAW

    MDR report key: 3830885 · Received May 23, 2014

    Report

    Report Number
    0001811755-2014-01921
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT, A STICKY TRIGGER WITH RUN-ON, WAS CONFIRMED. DURING THE INSPECTION THE SERVICE TECHNICIAN OBSERVED WHEN THE SAFETY BAR AND TRIGGER ARE DEPRESSED AT THE SAME TIME THE TRIGGER WOULD STAY IN A RUN POSITION AND THE HANDPIECE WOULD RUN-ON. UPON DISASSEMBLY, BOTH RUST AND CORROSION WAS FOUND ON THE TRIGGER ASSEMBLY. A TRIGGER FAILURE DUE TO CORROSION WAS IDENTIFIED AS THE PRIMARY FAILURE. CORROSION CAN OCCUR FROM EXPOSURE TO, OR IMMERSION IN, STEAM OR AQUEOUS SOLUTIONS FOR EXTENDED PERIODS OF TIME OR ON NUMEROUS OCCASIONS, AS IN NON-RECOMMENDED CLEANING AND STERILIZATION PRACTICES OR EXPOSURE TO CORROSIVE MATERIALS.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TRIGGER OF A SYSTEM 7 RECIP SAW WAS STICKING AT THE USER FACILITY, A CONDITION IN WHICH THE DEVICE HAS THE POTENTIAL TO RUN WITHOUT USER ACTIVATION. THIS EVENT OCCURRED DURING TESTING BY A MANUFACTURER FIELD SERVICE TECHNICIAN, SO THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TRIGGER OF A SYSTEM 7 RECIP SAW WAS STICKING AT THE USER FACILITY, A CONDITION IN WHICH THE DEVICE HAS THE POTENTIAL TO RUN WITHOUT USER ACTIVATION. THIS EVENT OCCURRED DURING TESTING BY A MANUFACTURER FIELD SERVICE TECHNICIAN, SO THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307451 SYSTEM 7 RECIP SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1