BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 7 SAG SAW

    MDR report key: 2925829 · Received January 22, 2013

    Report

    Report Number
    0001811755-2013-00044
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 3, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR EVALUATION; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED. (B)(4): THE DEVICE WAS RECEIVED FOR EVALUATION; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THERE WAS NO ACTIVE LEAKING OBSERVED, BUT A WHITE SOLID BUILDUP WAS FOUND INSIDE THE DEVICE. THE PRESENCE OF A SUBSTANCE THAT MAY HAVE EMITTED FROM THE HANDPIECE IS LIKELY TO BE CAUSED OR CONTRIBUTED TO BY FLUID INSIDE OF THE DEVICE. A SUBSTANCE LEAKING FROM THE HANDPIECE COULD HAVE BEEN CAUSED BY IMPROPER CLEANING AND STERILIZATION PRACTICES AT THE ACCOUNT SITE; HOWEVER, THIS WAS NOT DIRECTLY ABLE TO BE CONFIRMED.

    Description of Event or Problem · 1

    THE SYSTEM 7 SAGITTAK SAW WAS SENT FOR EVALUATION DUE TO LEAKING AN UNKNOWN SUBSTANCE DURING CLEANING. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 1

    THE SYSTEM 7 SAGITTAK SAW WAS SENT FOR EVALUATION DUE TO LEAKING AN UNKNOWN SUBSTANCE DURING CLEANING. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29544 SYSTEM 7 SAG SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1