BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOANER SYSTEM 6 RECIP SAW

    MDR report key: 3760746 · Received April 21, 2014

    Report

    Report Number
    0001811755-2014-01400
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    January 22, 2014
    Report Date
    March 25, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF THE BLADE FALLING OUT OF THE HANDPIECE WAS NOT ABLE TO BE DUPLICATED BY A MANUFACTURER REPAIR TECHNICIAN THROUGH FUNCTIONAL EVALUATION . UPON DISASSEMBLY FOR VISUAL EXAMINATION, NO COMPONENTS WERE IDENTIFIED WHICH WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED FAILURE. THE DEVICE WAS SERVICED FOR PREVENTIVE MAINTENANCE AND RETURNED TO THE USER FACILITY.

    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 DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE DEVICE WOULD NOT RETAIN A BLADE. IT WAS CONFIRMED THAT NOTHING FELL INTO THE SURGICAL SITE. 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 DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE DEVICE WOULD NOT RETAIN A BLADE. IT WAS CONFIRMED THAT NOTHING FELL INTO THE SURGICAL SITE. 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
    239390 LOANER SYSTEM 6 RECIP SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1