BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 7 SINGLE TRIGGER ROTARY

    MDR report key: 3173132 · Received June 17, 2013

    Report

    Report Number
    0001811755-2013-01400
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IS ONGOING; ADDITIONAL INFORMATION MAY BE SUBMITTED ONCE THE RESULTS ANALYSIS IS COMPLETE. FAILURE ANALYSIS IS ONGOING; ADDITIONAL INFORMATION MAY BE SUBMITTED ONCE THE RESULTS ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF RUN-ON WAS NOT DUPLICATED; HOWEVER IT WAS CONFIRMED THAT THE DEVICE HAD ROUGH TRIGGER OPERATION DUE TO A BUILDUP OF DEBRIS IN THE TRIGGER. THIS LIKELY OCCURRED DUE TO NON-RECOMMENDED CLEANING PROCEDURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM 7 SINGLE TRIGGER ROTARY CONTINUED TO RUN ONCE THE TRIGGER WAS RELEASED DURING A ROUTINE MAINTENANCE CHECK BY A STRYKER FIELD SERVICE TECHNICIAN. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM 7 SINGLE TRIGGER ROTARY CONTINUED TO RUN ONCE THE TRIGGER WAS RELEASED DURING A ROUTINE MAINTENANCE CHECK BY A STRYKER FIELD SERVICE TECHNICIAN. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273871 SYSTEM 7 SINGLE TRIGGER ROTARY INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1