BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.1MM STRAIGHT ROUTER

    MDR report key: 6965373 · Received October 20, 2017

    Report

    Report Number
    0001811755-2017-01964
    Event Type
    Malfunction
    Date Received
    October 20, 2017
    Date of Event
    September 25, 2017
    Report Date
    November 2, 2017
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HBE
    UDI-DI
    7613327096781
    PMA / PMN Number
    K143399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS INDICATE THAT DURING EVALUATION ABRASIVE WEAR ALONG THE FLUTE EDGE WAS OBSERVED WHICH SUGGESTS THE ROUTER MAY HAVE COME INTO CONTACT WITH A METAL INSTRUMENT WHILE IN USE. THIS MAY HAVE CONTRIBUTED TO THE ROUTER BREAK. THE ASSOCIATED ATTACHMENT IFU 5407-210-768 REV-A NOTES THE FOLLOWING WARNING; "DO NOT LET THE SPINNING CUTTING ACCESSORY COME INTO CONTACT WITH RETRACTORS OR OTHER METAL TOOLS. METAL SHAVINGS COULD DETACH FROM THE EQUIPMENT AND FALL INTO THE SURGICAL SITE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE ROUTER BROKE IN THE ATTACHMENT. IT WAS ALSO REPORTED THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WAS A 1 MINUTE DELAY TO OBTAIN AN ALTERNATIVE DEVICE. IT WAS ALSO REPORTED THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE ROUTER BROKE IN THE ATTACHMENT. IT WAS ALSO REPORTED THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WAS A 1 MINUTE DELAY TO OBTAIN AN ALTERNATIVE DEVICE. IT WAS ALSO REPORTED THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744619 1.1MM STRAIGHT ROUTER DRILLS, BURRS, TREPHINES & ACCESSORIES HBE STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN 7613327096781

    Patients

    Seq Age Sex Outcome Treatment
    1