BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FACETFUSE DRIVER

    MDR report key: 3004692 · Received March 12, 2013

    Report

    Report Number
    3005977257-2013-00002
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 27, 2013
    Manufacturer
    SPINEFRONTIER, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DAMAGED DRIVER WAS RETURNED AND TECHNICAL INSPECTION SHOWED EVIDENCE OF OVER TORQUING AND BREAKAGE. DAMAGED SECTION OF PART WAS NOT THE SAME LENGTH AS DRAWING SPECIFICATIONS. THE DAMAGED DRIVER WAS COMPARED TO BE CONFORMING DRIVER IN INVENTORY. THE LENGTH OF THE DAMAGED DRIVER WAS LESS THAN THAT OF THE INVENTORY DRIVER, CONFIRMING THAT A PIECE WAS MISSING. LOT HISTORY WAS REVIEWED AND WAS FOUND TO MEET ALL QUALITY REQUIREMENTS. FIELD REP CONFIRMED THAT THE TIP OF THE DRIVER HAD BROKEN OFF, BUT THAT THE SURGEON COULD NOT RECOVER THE BROKEN TIP FROM WITHIN THE SCREW HEAD. THE SCREW HEAD WAS THEN COVERED BY A ROD, WHICH WAS LOCKED INTO PLACE TO COMPLETE THE ASSEMBLY. THE BROKEN PIECE IS THEREFORE SECURED WITHIN THE IMPLANT. THIS MDR IS BEING FILED TO ADDRESS THAT THE BROKEN DRIVER PIECE IS EMBEDDED WITHIN THE SCREW HEAD WITHIN THE PATIENT. FIELD REP ALSO CONFIRMED THAT THE SURGEON HAD USED THE FACETFUSE DRIVER WITH THE PEDFUSE SYSTEM, WHICH IS NOT WITHIN THE PEDFUSE SURGICAL TECHNIQUE. THE SURGEON HAD USED THE FACETFUSE DRIVER WITH A POWER DRILL AND PARTS FROM THE PEDFUSE SYSTEM. THE FACETFUSE SURGICAL TECHNIQUE DOES NOT INDICATE THAT THE DRIVER CAN BE USED WITH PEDFUSE SYSTEM.

    Description of Event or Problem · 1

    WHILE SURGICALLY IMPLANTING PEDFUSE SYSTEM INTO A PATIENT, THE SURGEON USED A FACETFUSE DRIVER OUTSIDE OF THE SURGICAL TECHNIQUE AND BROKE THE TIP OF THE DRIVER OFF. THE FIELD REP CONFIRMED THAT THE TIP OF THE DRIVER HAD BROKEN OFF BUT WAS UNABLE TO BE RECOVERED WITHIN THE SET SCREW AND WAS LEFT EMBEDDED WITHIN THE SET SCREW WITHIN THE PATIENT. THE SURGEON THEN USED A DIFFERENT INSTRUMENT AND SURGERY CONTINUED AS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103307 FACETFUSE DRIVER DRIVER LXH SPINEFRONTIER, INC. 11-00037 2532002

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other