BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSIO ANTI-MIGRATION REAMER

    MDR report key: 1588233 · Received January 13, 2010

    Report

    Report Number
    1065595-2010-00001
    Event Type
    Malfunction
    Date Received
    January 13, 2010
    Date of Event
    December 10, 2009
    Report Date
    January 13, 2009
    Manufacturer
    FOLSOM METAL PRODUCTS, INC.
    Product Code
    HTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION INTO THE CAUSE OF THE DEVICE FAILURE REVEALED THAT THE DEVICE WAS NOT PROPERLY USED DURING THE PROCEDURE. THE DEVICE WAS HAMMERED ON AT LEAST TWICE DURING THE PROCEDURE, WHICH PUSHED THE TIP INTO UN-DRILLED BONE. THE ANTI-MIGRATION REAMER IS NOT DESIGNED TO BE HAMMERED INTO BONE AND THEN USED; RATHER IT IS DESIGNED TO BE PLACED INTO A PRE-DRILLED HOLE AND THEN USED. THE ANTI-MIGRATION REAMER WAS NOT ABLE TO WITHSTAND THE FORCE APPLIED WHEN THE SURGEON ATTEMPTED TO TURN IT IN SOLID BONE. THE DEVICE WAS BEING HAMMERED BECAUSE IT WAS EITHER NOT INSERTED PROPERLY INTO THE FACET JOINT PER THE INSTRUCTIONS, OR THE HOLE WAS NOT DRILLED TO THE APPROPRIATE DEPTH WITHIN THE JOINT. AFTER REVIEWING THE INFORMATION PROVIDED, FOLSOM METAL PRODUCTS, INC. IMPLEMENTED A DESIGN CHANGE TO THE ANTI-MIGRATION REAMER. THE DESIGN CHANGE HAS CREATED A REAMER WITH A THICKER NECK DIAMETER THAT INCREASES ITS STRENGTH. DISTRIBUTORS HAVE BEEN MADE AWARE OF THE UPDATED DESIGN CHANGE AND ALL ANTI-MIGRATION REAMERS ARE NOW MANUFACTURED IN ACCORDANCE WITH THE UPDATED DMR.

    Description of Event or Problem · 1

    A FUSIO ANTI-MIGRATION REAMER FAILED DURING A FACET FUSION PROCEDURE. THE REAMER WOULD NOT GO INTO THE HOLE DRILLED IN THE JOINT, SO THE SURGEON HAMMERED ON THE REAMER, THEN REMOVED IT, DRILLED OUT THE HOLE FURTHER, AND THEN RE-INSERTED THE REAMER. THE REAMER STILL DID NOT FIT AS IT NEEDED TO, SO THE SURGEON HAMMERED ON IT AGAIN, AND THEN BEGAN TO TURN IT. THE TIP OF THE REAMER THEN BROKE OFF AND THE SURGEON WAS UNABLE TO CONTINUE WITH THE FUSIO PROCEDURE. THE REAMER SHAFT AND TIP WERE REMOVED AND THE FACET JOINT WAS PACKED WITH BONE CHIPS TO ENCOURAGE FUSION, VERSUS THE BONE DOWEL THAT WOULD HAVE BEEN INSERTED WITH THE FUSIO PROCEDURE. THE ANTI-MIGRATION REAMER IS NOT AN INSTRUMENT DESIGNED TO WITHSTAND HAMMERING. IT IS DESIGNED TO FIT INTO A PROPERLY PRE-DRILLED HOLE AND FAILED AS A RESULT OF THE STRESS APPLIED TO IT DURING A PROCEDURE WITH AN INADEQUATELY DRILLED HOLE IN THE FACET JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUSIO ANTI-MIGRATION REAMER REAMER HTO FOLSOM METAL PRODUCTS, INC. 302.111 L09403

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR