BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE TRIGGER ROTARY

    MDR report key: 3895108 · Received June 25, 2014

    Report

    Report Number
    0001811755-2014-02269
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 29, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED, BUT THE EVALUATION HAS NOT YET BEGUN. ADDITIONAL INFORMATION MAY BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT, TRIGGER FELL OUT, WAS CONFIRMED. THROUGH INSPECTION, THE SERVICE TECHNICIAN NOTED THAT THE TRIGGER SHAFT WAS TAPED TO THE HANDLE WITH THE TRIGGER PIN AND SPRING MISSING. THE TECHNICIAN ALSO NOTED THAT THE TRIGGER HOUSING WAS STILL ATTACHED TO THE HANDLE. UPON FURTHER INVESTIGATION OF THE TRIGGER HOUSING BY SR. MANUFACTURING ENGINEER, A SMALL CRACK WAS FOUND ON THE MAIN HOUSING, A CRACKED TRIGGER HOUSING MAY CAUSE OR CONTRIBUTE TO THE TRIGGER ASSEMBLY FALLING APART AND OUT OF THE HANDPIECE. THE TRIGGER ASSEMBLY WAS REPLACED ALONG WITH OTHER PREVENTATIVE MAINTENANCE, AND THE REPAIRED HANDPIECE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TRIGGER WAS BROKEN AND IT FELL OUT OF THE HANDPIECE BEFORE A SURGICAL PROCEDURE AT USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACK-UP EQUIPMENT. NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TRIGGER WAS BROKEN AND IT FELL OUT OF THE HANDPIECE BEFORE A SURGICAL PROCEDURE AT USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACK-UP EQUIPMENT. 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
    371257 SINGLE TRIGGER ROTARY INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1