BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.3MM TAPERED ROUTER

    MDR report key: 7078435 · Received December 4, 2017

    Report

    Report Number
    0001811755-2017-02393
    Event Type
    Injury
    Date Received
    December 4, 2017
    Date of Event
    November 4, 2017
    Report Date
    December 26, 2017
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HBE
    UDI-DI
    7613327096729
    PMA / PMN Number
    K143399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS INDICATE THAT THE ROUTER BROKE DUE TO A SUDDEN HARD IMPACT. HEAVY IMPACT MARKS ARE ALSO EVIDENT ALONG THE FLUTE EDGE INDICATING POSSIBLE CONTACT WITH METAL. THE HARD SUDDEN IMPACT MAY HAVE CAUSED THE FRACTURE OF THE ROUTER. THE IFU FOR THE ATTACHMENT (5407-210-768 REV-B) HAS THE FOLLOWING WARNING; "DO NOT APPLY EXCESSIVE PRESSURE, SUCH AS BENDING OR PRYING, WITH THE CUTTING ACCESSORY, FOOT, OR LEG. EXCESSIVE PRESSURE MAY FRACTURE THE CUTTING ACCESSORY OR BEND THE ATTACHMENT FOOT OR LEG." " 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." THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRANIAL PROCEDURE, THE ROUTER BROKE. IT WAS ALSO REPORTED THAT A PIECE WENT THROUGH TO THE BRAIN OF THE PATIENT AND THE CONSEQUENCES FOR THE PATIENT ARE NOT YET KNOWN. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRANIAL PROCEDURE, THE ROUTER BROKE. IT WAS ALSO REPORTED THAT A PIECE WENT THROUGH TO THE BRAIN OF THE PATIENT AND THE CONSEQUENCES FOR THE PATIENT ARE NOT YET KNOWN. NO FURTHER INFORMATION WAS PROVIDED. IT WAS SUBSEQUENTLY REPORTED THAT PATIENT REQUIRED A DECOMPRESSION IN THE TEMPORAL REGION DUE TO AN INFECTION WHICH WAS SUCCESSFUL. THE BROKEN PIECE HAS MADE CONTACT WITH THE PARENCHYMA AND WAS LOST UNDER APPROXIMATELY 2MM UNDER THE SURFACE. IT WAS ALSO REPORTED THAT THE SURGEON STATED THAT ANY ADVERSE CONSEQUENCE IS NOT TO BE EXPECTED, BOTH PATIENT AND FAMILY HAVE BEEN INFORMED. IT WAS FURTHER REPORTED THAT AN ADDITIONAL POST-OP CT-SCAN WAS NEEDED, TO REMOVE THE BROKEN PIECE IN A SECOND SURGERY, UNDER NAVIGATION. MEANWHILE, BETWEEN THE FIRST AND SECOND SURGERY, THE PATIENT WAS HELD UNDER ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860397 2.3MM TAPERED ROUTER DRILLS, BURRS, TREPHINES & ACCESSORIES HBE STRYKER INSTRUMENTS-KALAMAZOO 17178097 7613327096729

    Patients

    Seq Age Sex Outcome Treatment
    1 Other