BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIALIF SYSTEM

    MDR report key: 918452 · Received March 23, 2007

    Report

    Report Number
    3004578806-2007-00006
    Event Type
    Malfunction
    Date Received
    March 23, 2007
    Date of Event
    February 26, 2007
    Report Date
    March 8, 2007
    Manufacturer
    TRANS1 INCORPORATED
    Product Code
    JDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SECTION A: WEIGHT, HEIGHT, AGE, GENDER ARE UNKNOWN TO THE MANUFACTURER. THE PATIENT IDENTIFIER ASSIGNED CORRESPONDS TO THE MANUFACTURER'S CUSTOMER FEEDBACK TRACKING. SECTION E: AS FAR AS THE MANUFACTURER IS AWARE, THE USER FACILITY IS NOT REPORTING THIS EVENT. THIS IS CONSISTENT WITH PART 803 SINCE NO SERIOUS INJURY OR DEATH OCCURRED. SECTION: AN INVESTIGATION OF THIS EVENT WAS CONDUCTED IN ACCORDANCE WITH INTERNAL PROCEDURES AND APPLICABLE REGULATION. SEE ATTACHED EVALUATION SUMMARY FOR ADDITIONAL INFORMATION. SECTION: THE CODE WAS SELECTED WITH "OTHER" MEANING THAT THE MANUFACTURING PROCESS, DESIGN, INSPECTION, TESTING, LOT RECORDS, TRAINING, ETC. WERE EVALUATED. THIS EVENT DID NOT CAUSE DEATH, SERIOUS INJURY, OR REQUIRE MEDICAL INTERVENTION. THE EVENT IS BEING REPORTED BY THE MANUFACTURER BECAUSE OF THE POSSIBILITY OF FUTURE RECURRENCE AND THE POTENTIAL FOR RECURRENCE TO RESULT IN SERIOUS INJURY. THE MANUFACTURER DOES NOT BELIEVE THAT RECURRENCE WOULD RESULT IN DEATH. THE MANUFACTURER BELIEVES THE RECURRENCE OF THIS EVENT IS UNLIKELY TO RESULT IN SERIOUS INJURY BUT IT MAY BE POSSIBLE IF THE BLADE WERE TO MIGRATE OUT OF THE DISC SPACE. THIS REPORT IS MADE IN ORDER TO FOLLOW THE MOST CONSERVATIVE REPORTING PATHWAY. SUMMARY OF INVESTIGATION: THE BLADE MANUFACTURING PROCESS AND BLADE DESIGN WERE EVALUATED AND FOUND TO BE IN COMPLIANCE WITH INTERNAL PROCEDURES AND VALIDATION PARAMETERS. IT IS KNOWN THAT THE NITINOL MATERIAL OF THE CUTTER BLADE CAN FRACTURE. GIVEN THIS POTENTIAL FOR FRACTURE, THE BLADES ARE DESIGNED TO BREAK ON THE LOWER LOOP FIRST AND SUCH THAT BOTH LEGS OF THE LOOP CANNOT BREAK SIMULTANEOUSLY. UPON FRACTURE OF THE LOWER LOOP, THE BLADE REMAINS ATTACHED TO THE SHAFT AND CAN BE SAFELY REMOVED. ANY BLADE FRACTURE IS EASILY DETECTED BY THE USER BY THREE MEANS: TACTILE FEEL THROUGH THE HANDLE, AUDIBLE SOUND, AND VISUALLY VIA FLUOROSCOPE. THE LOOP DESIGN IS VALIDATED AND THE FAILURE MODE HAS BEEN EXTENSIVELY TESTED. THE BLADE LOT AND THE SPECIFIC CUTTER USED IN THE CASE WERE EVALUATED. THE LOT OF BLADES FROM WHICH THE SUBJECT BLADE CAME WAS MANUFACTURED, INSPECTED, TESTED, AND DOCUMENTED AS REQUIRED BY INTERNAL PROCEDURES. TESTING INCLUDES DESTRUCTIVE TEST TO FAILURE OF SOME MEMBERS OF THE LOT. IF ANY MEMBERS OF THE LOT FAIL THE DESTRUCTIVE TEST, THE ENTIRE LOT IS REJECTED. THERE IS NO EVIDENCE THAT THE BATCH OF BLADES CONTAINED ANY BLADES THAT WERE UNSUITABLE FOR THEIR NORMAL INTENDED USE. THE CUTTER THAT WAS RETURNED TO THE MANUFACTURER WAS VISUALLY EXAMINED AND PHOTOGRAPHED. SINCE THE BLADE WAS NO LONGER ATTACHED, IT WAS POSSIBLE TO COLLECT LITTLE USEFUL DATA. INVESTIGATIONAL CONCLUSIONS: DURING NORMAL INTENDED USE AND EVEN UNDER HIGHLY ABUSIVE CONDITIONS, THE CLOSED LOOP CUTTERS ARE HIGHLY RESISTANT TO FRACTURE. THE BLADES ARE DESIGNED AND ALL TESTING CONFIRMS THAT WHEN FRACTURES DO OCCUR, THE LOOP SECTIONS DO NOT FRACTURE SIMULTANEOUSLY OR RESULT IN THE BLADE BECOMING DETACHED FROM THE CUTTER BODY. NO EVIDENCE CAN BE FOUND TO INDICATE THAT THE FAILURE IN 2007, WAS THE RESULT OF A DESIGN OR MANUFACTURING ISSUE. THE MOST PROBABLE CAUSE WAS FAILURE OF THE USER TO DETECT THE INITIAL BREAK IN THE LOWER LEG OF THE LOOP AND FURTHER FAILURE TO SAFELY REMOVE THE CUTTER PRIOR TO A SUBSEQUENT BREAK OF THE UPPER LEG OF THE LOOP. AS WITH PRIOR INSTANCES OF THIS FAILURE MODE, THE SURGEON HAD LITTLE EXPERIENCE IN USING THE INSTRUMENT IN A LIVE CASE.

    Description of Event or Problem · 1

    LARGE RADIAL DOWNCUTTER FRACTURED DURING PROCEDURE. SURGEON UNSUCCESSFULLY ATTEMPTED TO REMOVE CUTTER TIP. TIP OF CUTTER WAS NOT REMOVED AND WAS LEFT IN THE DISC SPACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIALIF SYSTEM ANTERIOR SPINAL FIXATION JDN TRANS1 INCORPORATED NA 043229806

    Patients

    Seq Age Sex Outcome Treatment
    1 YR