BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXP 6.35 TI CLSD POLY 10X90

    MDR report key: 6504761 · Received April 19, 2017

    Report

    Report Number
    1526439-2017-10270
    Event Type
    Malfunction
    Date Received
    April 19, 2017
    Report Date
    March 24, 2017
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    K111136
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE EXPEDIUM 6.35 TI CLOSED 10 X 90 MM POLYAXIAL SCREW (PRODUCT CODE: 1799-19-090) WAS RETURNED TO THE CUSTOMER QUALITY UNIT. THE CLOSED POLYAXIAL SCREW WAS RETURNED IN TWO SEPARATE PIECES ¿ THE TULIP HEAD AND THE SCREW SHANK. THE TULIP HEAD WAS RETURNED WITH TWO LARGE GASHES ON OPPOSING SIDES, A SET SCREW IN ITS THREADS, NO FLEX BALL, AND A SADDLE ROTATED APPROXIMATELY 30 DEGREES TO ONE SIDE. THE GASHES APPEAR TO BE MACHINE MADE IN AN ATTEMPT TO FREE THE SCREW FROM THE PATIENT¿S SPINE. THE GASHES CUT NEARLY ALL THE WAY THROUGH EACH SIDE OF THE TULIP HEAD TO SUCH A DEGREE THAT THE TULIP HEAD VISIBLY FLEXES WHEN FORCE IS APPLIED TO ITS EDGES. THE SET SCREW APPEARS TO HAVE BEEN USED IN CONJUNCTION WITH A ROD IN AN ATTEMPT TO REMOVE THE SCREW STUCK IN THE PATIENT¿S VERTEBRA. ALTHOUGH IT IS LODGED INSIDE THE TULIP HEAD, THERE DOES NOT APPEAR TO BE ANY DAMAGE TO THE SET SCREW. IT CAN ROTATE APPROXIMATELY ONE THIRD OF A TURN BEFORE BEING HALTED ON EITHER SIDE. THIS MAY BE DUE TO THE GASHES ON EITHER SIDE OF THE TULIP HEAD. THE FLEX BALL IS MISSING ENTIRELY, BUT THIS MAY BE DUE TO A NUMBER OF REASONS, INCLUDING IT BEING CUT BY THE INSTRUMENT USED TO CUT THE TULIP HEAD, DROPPED WHEN THE TULIP HEAD WAS REMOVED FROM THE SCREW SHANK, OR A COMBINATION THEREOF. THE SADDLE MOVES SOMEWHAT FREELY IN THE REMAINS OF THE SCREW HEAD THOUGH IT REMAINS ROTATED APPROXIMATELY 30 DEGREES IN THE REMAINS OF THE TULIP HEAD. THE SADDLE FEATURES A CUT ON ONE SIDE WHICH APPEARS TO BE FROM THE CUTTING TOOL. IT CANNOT BE ACCURATELY DETERMINED WHEN THE SADDLE WAS ROTATED, THOUGH THIS MAY HAVE OCCURRED WHEN THE TULIP HEAD WAS FORCIBLY REMOVED FROM THE SCREW SHANK. PLACING HIGH LEVELS OF STRESS ON THE TULIP HEAD, ESPECIALLY AT AN EXTREME ANGLE IN RELATION TO THE SCREW SHANK, MAY BE SUFFICIENT TO FORCE THE SADDLE TO SHIFT/ROTATE IN THE TULIP HEAD. WITHOUT THE LOT NUMBERS, NO REVIEW OF THEIR MANUFACTURING RECORDS COULD BE COMPLETED. NO EMERGING TRENDS WERE FOUND REQUIRING FURTHER ACTIONS. THE ROOT CAUSE OF THE SCREW FALLING APART CANNOT BE DETERMINED FROM THE SAMPLE AND THE INFORMATION PROVIDED. A POTENTIAL ROOT CAUSE MAY BE EXCESSIVE FORCE PLACED ON THE SCREW IN AN ATTEMPT TO REMOVE IT FROM ITS POSITION IN THE VERTEBRA. THIS APPEARS TO HAVE COME ABOUT DUE TO THE STRIPPING OF THE DRIVE FEATURE INSIDE THE SCREW¿S HEAD, NECESSITATING OTHER MEANS TO REMOVE THE SCREW. THE CUTS INTO THE SIDE OF THE SCREW APPEAR TO HAVE BEEN SUFFICIENT TO SEPARATE THE TULIP HEAD FROM THE SCREW SHANK, ALLOWING FOR THE SHANK TO BE REMOVED USING OTHER MECHANICAL MEANS. NO SYSTEMIC TRENDS REQUIRING IMMEDIATE ACTION HAVE BEEN OBSERVED, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS WAS A REVISION CASE WHERE THE INITIAL SURGERY (INITIAL SURGERY DATE UNKNOWN) WAS A T10-PELVIS USING EXPEDIUM 5.5 AND DEVEX. FOR THE REVISION, WE CUT THE OLD 5.5 MM COCR RODS BELOW THE L2 SCREWS AND REMOVED THE L3,L4,L5,S1 AND SAI SCREWS BILATERALLY. WE REIMPLANTED THE OLD SCREW HOLES WITH EXPEDIUM 6.35 USING COCR RODS AND IN-LINE 5.5-6.35 DOMINOS TO MAKE THE CONNECTION. WE ALSO ADDED A THIRD 6.35 MM COCR ROD WITH TWO CONNECTORS (CLOSED-OPEN 6.35-5.5/6.35 DOMINOS). TO START OFF THE PROCEDURE, THE SURGEONS EXPOSED FROM L2-PELVIS. THEN THEY USED A METAL CUTTING BURR TO CUT THE OLD 5.5 MM RODS JUST BELOW THE L2 SCREWS BILATERALLY. THEN WE EASILY REMOVED ALL OF THE SET SCREWS AND RODS. AS WE TOOK OUT THE EXPEDIUM 5.5 SCREWS, WE WROTE DOWN EVERYTHING EXPLANTED FOR FUTURE REFERENCE (EXPLANT/IMPLANT LIST REFERENCE BELOW). ALL OF THE L3,L4,L5,S1 AND SAI SCREWS CAME OUT WITH EASE. UPON REMOVAL, WE BEGAN TO RE-INSTRUMENT USING NEW EXPEDIUM 6.35 SCREWS. AT THE RIGHT SCREW, WE FIRST UPSIZED THE INITIAL SCREW (5 X 40) TO A 6 X 40 MM. THE SURGEON FELT THIS SCREW WAS TOO LOOSE SO HE TOOK IT OUT AND REPLACED IT WITH A LARGER SCREW YET, A 7 X 50 MM POLYAXIAL SCREW. WHEN IT CAME TIME TO IMPLANT NEW SAI SCREWS, WE WERE USING A 9 X 90 MM CLOSED HEAD SCREW (1799-19-990 LOT #TBJIN) ON THE PATIENT¿S LEFT SIDE. THE SURGEON BEGAN TO IMPLANT THE SCREW MANUALLY WITH A RATCHET T-HANDLE WHEN THEY NOTICED IT WAS TOO LOOSE AND WE WOULD NEED TO UPSIZE THE SCREW FOR BETTER FIXATION. DUE TO THE 9 MM SCREW BEING LOOSE, WE DID NOT TAP THE HOLE PRIOR TO PLACING THE 10 X 90 MM CLOSED HEAD SAI SCREW (1799-19-090 LOT# UNKNOWN). WHEN THE SURGEON WAS PLACING THE SCREW, IT BEGAN TO BECOME REALLY TIGHT HALFWAY THROUGH INSERTION. AT THIS POINT, I RECOMMENDED THE SURGEON STOP INSERTING, BACK OUT THE SCREW ENTIRELY, AND TAP USING A 10 MM VIPER SAI TAP. THE SURGEON DID THIS AND TAPPED ALL 90 MM AND SAID THE TAP FELT LIKE IT WAS GETTING GOOD PURCHASE BUT IT WAS NOT TOO TOUGH TO INSERT ENTIRELY TO 90 MM. THE SURGEON THEN TRIED TO INSERT THE 10 X 90 SCREWS AGAIN AND IT GOT STUCK ABOUT ¾ OF THE WAY INSERTED. IT WAS STUCK SO TIGHT THAT HE ENDED UP STRIPPING THE FLANGES ON THE T27 MIS POLY SCREWDRIVER (2797-18-101 LOT#G0211). BECAUSE OF THIS, THE INNER DRIVE MECHANISM OF THE 10 X 90 SAI SCREW WAS SHOT BUT THE SCREW WAS STILL NOT FULLY INSERTED BY ABOUT 2 CM. AT THIS POINT WE HAD NO OTHER OPTION BUT TO BACK OUT THE SCREW. WE TRIED THE ¿WHIRLY BIRD¿ TECHNIQUE FIRST. WE CUT A SMALL PIECE OF 6.35 ROD, INSERTED IT INTO THE HEAD OF THE 10 X 90 SAI SCREW, AND FINAL TIGHTENED A CLOSED HEAD SET SCREW (1797-61-000 LOT#UNKNOWN). ALTHOUGH FINAL TIGHTENED, THE POLY HEAD COULD STILL MOVE WHEN WE TRIED TO BACK OUT THE SCREW USING THE COUNTERTORQUE. WE TRIED TO TIGHTEN DOWN THE SET SCREW AT 100 IN-LB. AND STILL TOO LOOSE. WE TRIED TO TIGHTEN WITH THE MEDIUM TIGHTENER AND STILL THE POLY HEAD ROTATED. OUR LAST ATTEMPT WAS TO KEEP THE X25 FINAL TIGHTENER SHAFT (2797-12-600 LOT#GM4660901) IN THE SET SCREW, FIND THE APPROPRIATE FEMALE HEX SIZE ADAPTER (OUT OF THE HOSPITAL SCREW REMOVAL SET) THAT WOULD ALLOW THE SURGEON TO TIGHTEN DOWN THE SET SCREW USING THE FINAL TIGHTENER SHAFT WITH A SOLID T-HANDLE TO TIGHTEN THE SET SCREW AS TIGHT AS HUMANLY POSSIBLE. THIS IS WHEN THE X25 FINAL TIGHTENER SHAFT BROKE. THE TIP SHEARED RIGHT OFF AND REMAINED IN THE SCREW HEAD. THE SURGEON ATTEMPTED ONE LAST TIME TO BACK OUT THE SCREW AND WAS UNSUCCESSFUL. OUR NEXT REMOVAL OPTION OF CHOICE WAS TO CUT OFF THE POLY HEAD FROM THE 10 X 90 SAI SCREW AND USE A PAIR OF TREPHINES AND SYNTHES FEMALE EASY-OUTS (9 MM: 03.611.019 LOT#565861F06, 8 MM: 03.611.018 LOT# 566761G06). AFTER ABOUT 10 MINUTES AND A LOT OF FORCE, THE SURGEON WAS FINALLY ABLE TO BACK OUT THE SCREW USING THE 9 MM SYNTHES FEMALE EASY-OUT. WITH THE BROKEN SCREW AND ALL FRAGMENTS SUCCESSFULLY REMOVED, WE WERE ABLE TO IMPLANT THE SAME SCREW, 10 X 90 MM CLOSED HEAD SAI, ON POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287002 EXP 6.35 TI CLSD POLY 10X90 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1