BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 7 SAG SAW

    MDR report key: 2934336 · Received January 30, 2013

    Report

    Report Number
    0001811755-2013-00101
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 16, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2013: THE REPORTED EVENT WAS CONFIRMED. DURING THE VISUAL INSPECTION, THE DIAGNOSTIC ENGINEER CONFIRMED A RED SOLID SUBSTANCE VISIBLE NEAR THE INDEXING BUTTON OF THE SAG HEAD. BASED ON THE FUNCTIONAL INSPECTION, THE SUBSTANCE IS A PRE-APPLIED LOCTITE THREAD LOCKER. THIS FAILURE IS MOST LIKELY ATTRIBUTED TO A MANUFACTURING ISSUE. THE LOANER DEVICE WAS REPAIRED AND PUT BACK INTO STRYKER STOCK.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT BEING RETURNED FOR EVALUATION AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AND THE DEVICE IS RETURNED A FOLLOW UP REPORT WILL BE SUBMITTED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AND THE DEVICE IS RETURNED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM 7 SAGITTAL SAW WAS LEAKING AN UNKNOWN FLUID FOLLOWING CLEANING. THIS RESULTED IN A 1 HOUR DELAY TO A SURGICAL PROCEDURE. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THIS EVENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM 7 SAGITTAL SAW WAS LEAKING AN UNKNOWN FLUID FOLLOWING CLEANING. THIS RESULTED IN A 1 HOUR DELAY TO A SURGICAL PROCEDURE. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THIS EVENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40410 SYSTEM 7 SAG SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1