BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSKELETON® TCS NO 6 SWIVEL DRIVER

    MDR report key: 5397347 · Received January 28, 2016

    Report

    Report Number
    3006340236-2015-00018
    Event Type
    Malfunction
    Date Received
    January 28, 2016
    Date of Event
    May 28, 2015
    Report Date
    January 27, 2016
    Manufacturer
    TITAN SPINE, LLC
    Product Code
    HXX
    UDI-DI
    M682521010050
    PMA / PMN Number
    K142940
    Removal / Correction Number
    9099519-02/18/2015-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A RETROSPECTIVE MEDICAL DEVICE REPORT FOR A COMPLAINT ON THE SUBJECT DEVICE. IT WAS DETERMINED THIS COMPLAINT REQUIRED A MEDICAL DEVICE REPORT AFTER A REVIEW OF MEDICAL DEVICE REPORT DETERMINATION PROCEDURES. PATIENT INFORMATION IS NOT AVAILABLE FOR THIS REPORT. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE SUBJECT DEVICE. THE REVIEW REVEALED THERE WERE NO ANOMALIES OR DISCREPANCIES WERE NOTED WITHIN THE DEVICE HISTORY RECORDS FOR THE PRODUCT OF THE SUBJECT DEVICE LOT. ALL RECORDS SHOWED PRODUCT MET SPECIFICATIONS AND PASSED THE INCOMING INSPECTION. THE SUBJECT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED. THE TIP OF THE SUBJECT DEVICE SHEARED OFF OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. A RECALL WAS INITIATED IN FEBRUARY 2015 TO RETURN AND QUARANTINE SUBJECT INSTRUMENT LOT. THROUGH CAPA INVESTIGATIONS, IT WAS DETERMINED THE NO 6 HEXALOBULAR DRIVER DESIGN WAS DEFICIENT. THE 510(K) K151596 WAS SUBMITTED AND APPROVED TO CHANGE THE HEXALOBULAR SIZE TO A NO 8.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A CERVICAL FUSION PROCEDURE AT C6-C7. THE SURGEON FOLLOWED THE CORRECT PROCEDURE BY UTILIZING THE PUNCH AWL BEFORE PLACING THE SCREW. THE PUNCH AWL ANGLE TRAJECTORY AND DEPTH WAS ANALYZED UNDER FLUORO. A TCS SWIVEL HEX DRIVER WAS USED TO INSERT A 3.5MM X 14MM LOCKING SCREW INTO C6. DURING FINAL X-RAY, THE CAGE AND TWO SCREW CONSTRUCT WERE IDENTIFIED AS BEING PLACED TOO OFF MIDLINE TO THE PATIENT ANATOMY. THE SURGEON WENT TO REMOVE THE SCREW IN C6; HOWEVER, THE SURGEON COULD NOT RE-ENGAGE THE HEX DRIVER INTO THE SCREW HEAD. UNDER THE MICROSCOPE, THE SURGEON IDENTIFIED THE DISTAL TIP OF THE HEX DRIVER HAD PARTIALLY BROKEN OFF INTO THE SCREW HEAD. THE IMPLANT WAS REMOVED BY THE SURGEON BURRING THE BONE OF THE C6 VERTEBRAE DIRECTLY ABOVE THE SCREW HOLE. THE REMOVAL OF BONE ANTERIOR TO THE SCREW ALLOWED THE SURGEON TO REMOVE THE IMPLANT DEVICE WITH THE SCREW STILL ENGAGED. THE PROCEDURE WAS FINISHED USING ANOTHER CERVICAL STANDALONE SYSTEM. NO ADVERSE EFFECTS OR INJURY TO THE PATIENT AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56579 ENDOSKELETON® TCS NO 6 SWIVEL DRIVER HEX DRIVER HXX TITAN SPINE, LLC G150101 M682521010050

    Patients

    Seq Age Sex Outcome Treatment
    1