BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FACETFUSE DRILL

    MDR report key: 2820301 · Received October 31, 2012

    Report

    Report Number
    3005977257-2012-00016
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 31, 2012
    Manufacturer
    SPINEFRONTIER
    Product Code
    MRW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY AND LOT HISTORY DID NOT INDICATE ANY CHANGES IN THE DESIGN OR MFG THAT WOULD CONTRIBUTE TO THE BREAKING OF THE BIT. A REVIEW OF THE BROKEN BIT ITSELF DID NOT REVEAL ANY DEFICIENCIES THAT WOULD CONTRIBUTE TO THE BREAKING OF THE BIT. THE FACETFUSE DRILL BIT WAS SUBJECTED TO A FORCE THAT WAS GREAT ENOUGH TO CAUSE THE BREAKAGE. SURGEONS THAT CHANGE THE TRAJECTORY OF A DRILL BIT WHILE DRILLING RUN THE RISK THAT THE FORCE BEING PLACED ON IT CAN CAUSE IT TO BREAK. IN THIS CASE THE SURGEON WAS LEANING DOWN ON THE DRILL TRYING TO GET THE DESIRED TRAJECTORY, WHICH CAUSED THE BIT TO BEND AND BREAK. THE FACETFUSE SURGICAL TECHNIQUE HAS THE WARNING "DO NOT CHANGE TRAJECTORY OF DILL WHEN DRILLING. IF TRAJECTORY NEEDS TO BE CORRECTED REMOVE DRILL COMPLETELY AND RE-DRILL PILOT HOLE." THIS IS ON THE SAME PAGE AS THE STEP THAT DEMONSTRATES HOW TO PREPARE THE SCREW HOLE WITH THE DRILL. EVAL SUMMARY: FACETFUSE MIS SCREW SYSTEM SURGICAL TECHNIQUE ((B)(4)).

    Description of Event or Problem · 1

    SURGEON WAS PERFORMING A PROCEDURE WITH FACETFUSE MIS SCREW SYSTEM AND WAS USING THE FACETFUSE DRILL BIT (PART NUMBER (B)(4)) TO CREATE PILOT HOLES FOR PLACEMENT OF FACETFUSE SCREWS. HE WAS ATTEMPTING TO GET THE DESIRED TRAJECTORY BY LEANING ON THE DRILL, WHICH CAUSED IT TO BEND AND BREAK. THE DISTAL END OF THE DRILL BIT REMAINED IN THE INFERIOR FACET OF L5 OF THE PT, WHILE THE PROXIMAL END REMAINED IN THE DRILL ASSEMBLY. THE SURGEON REMOVED THE INFERIOR FACET OF L5 FROM THE PT IN ORDER TO REMOVE THE DRILL BIT, AND USED AN INTERSPINOUS PLATE FOR FIXATION, INSTEAD OF A FACET SCREW. IN TOTAL 20 MINUTES WERE ADDED TO THE SURGERY, AND NO ADD'L BLOOD WAS NECESSARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FACETFUSE DRILL DRILL, SOLID, 03.5MM X 50MM MRW SPINEFRONTIER 11-00032 30307

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention