BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI MATRIX SCREW 45MM THREAD LENGTH

    MDR report key: 3070539 · Received April 22, 2013

    Report

    Report Number
    2530088-2013-10440
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    August 26, 2011
    Report Date
    August 26, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ORIGINAL AWARENESS DATE IS (B)(4) 2011. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SYNTHES, OR ITS EMPLOYEES THAT THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. MANUFACTURING EVALUATION REPORTS THAT THE PART WAS RECEIVED ASSEMBLED AND LOCKED IN PLACE WITH THE BODY/COLLET AS WELL AS A SECTION OF CURVED ROD AND A LOCKING SCREW. THE BONE THREAD SHOWS MARKS ON THE MAJOR DIAMETER NOT CONSISTENT WITH MANUFACTURING. THE LOCKING CAP THREADS INTERFACE ONLY WITH THE MATING POLYAXIAL HEAD THREADS. THE BONE SCREW FUNCTIONS INDEPENDENTLY FROM THE LOCKING CAP AND POLYAXIAL HEAD; THEREFORE, THE BONE SCREW IS NOT RELATED TO THE COMPLAINT CONDITION. THE LOT NUMBER IS UNKNOWN THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED. PRODUCT DEVELOPMENT EVALUATION REVEALS, THE SCREW, LOCKING CAP, AND 2 PIECES OF ROD WERE RETURNED. ONE ROD PIECE WAS ASSEMBLED WITH THE SCREW AND CAP. IT WAS EVIDENT THAT THE ROD HAD BEEN CUT IN PLACE NEAR THE SCREW HEAD. THE LOCKING CAP WAS TIGHT, BUT WAS ABLE TO BE REMOVED WITH A STANDARD SCREWDRIVER AND STANDARD COUNTERTORQUE TUBE, WITH OUT ANY DAMAGE TO THE DRIVER. THE DESIGN OF THE SYSTEM COMPONENTS ASSOCIATED WITH THIS COMPLAINT IS APPROPRIATE FOR THE CLINICAL INDICATIONS. IT WAS NOTED THAT THE LONG SCREWDRIVER SHAFTS WERE USED TO LOOSEN THE CAP WITH THE SHORT COUNTERTORQUE TUBE DURING THE PROCEDURE. THIS SETUP HAS THE POTENTIAL FOR OFF-AXIS LOADING OF THE DRIVERS WHICH CAN RESULT IN THE DRIVER YIELDING OR BREAKING BEFORE ENOUGH TORQUE IS GENERATED TO REMOVE THE CAP. THE TORQUE LIMITING HANDLE USED IN THIS CASE WAS NOT RETURNED FOR EVALUATION OF THE TORQUE PERFORMANCE. IT IS INCONCLUSIVE WHETHER THE HANDLE WAS PROPERLY CALIBRATED OR NOT. THE TECHNIQUE GUIDE DISCUSSES THE PROPER STEPS AND INSTRUMENTATION REQUIRED FOR REMOVING A LOCKING CAP. THIS COMPLAINT IS DEEMED INDETERMINATE. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A L5-S1 LUMBAR FUSION PROCEDURE, THE FINAL X-RAYS WERE TAKEN AFTER IMPLANTING HARDWARE ON (B)(6) 2011. X-RAYS SHOWED THAT THE ANGLE OF THE 6.0MM MATRIX SCREW AT L5 NEEDED READJUSTING. THE SURGEON REMOVED THE MATRIX LOCKING CAP FROM S1 WHILE THE 7.0MM MATRIX SCREW AND MATRIX TOP LOADING POLYAXIAL HEAD AT S1 REMAINED INTACT. THE SURGEON ATTEMPTED SEVERAL DIFFERENT TECHNIQUES TO REMOVE THE MATRIX LOCKING CAP, MATRIX TOP LOADING POLYAXIAL HEAD AND MATRIX SCREW AT L5. USING DIFFERENT TECHNIQUES IN AN ATTEMPT TO REMOVE THE LOCKING CAP AT L5, THE FOLLOWING INSTRUMENTATION BECAME DAMAGED, THE 10NM TORQUE LIMITING RATCHET TO REMOVE THE LOCKING CAPS, THE 1ST LOCKING CAP AT S1 WAS REMOVED. WHILE TRYING TO REMOVE THE 2ND LOCKING CAP AT L5, THE DEVICE WOULD NOT TURN AND THE LOCKING CAP COULD NOT BE REMOVED. THE RATCHET T-HANDLE STRIPPED WHEN PUT IN NEUTRAL. THE TEETH ON BOTH T25 STAR-DRIVE SHAFTS BENT AND THE TEETH ON THE SPORT GRIP T25 STAR-DRIVE BENT. SURGEON WAS NOT ABLE TO REMOVE THE LOCKING CAP AT L5 AND DECIDED TO CUT THE 5.5MM CURVED ROD IN HALF AND BACK OUT THE L5 SCREW AND POLYAXIAL HEAD WITH A PAIR OF VICE GRIPS. A NEW SCREW, LOCKING CAP AND POLYAXIAL HEAD WAS PLACED AT L5 AND PROCEDURE WAS COMPLETED. APPROXIMATELY 30-45 MINUTES WAS ADDED TO PROCEDURE. THIS IS 1 OF 3 REPORTS FOR THE SAME EVENT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172080 6.0MM TI MATRIX SCREW 45MM THREAD LENGTH NKB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention