BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM BLOCKER

    MDR report key: 2943390 · Received February 5, 2013

    Report

    Report Number
    3005525032-2013-00001
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 8, 2013
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    KWP
    PMA / PMN Number
    K071373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.

    Additional Manufacturer Narrative · 1

    RESULTS: VISUAL INSPECTION: THREE BLOCKERS WERE RETURNED IN TWO SEPARATE PACKAGES. BLOCKER FOUND IN PACKAGING MARKED "S1 RIGHT BLOCKER": BOTTOM SURFACE IS DEFORMED. THE MARKS LEFT BY A ROD ARE VISIBLE. THEY ARE NOT VERY WELL DEFINED. ONE DEFORMATION IS DEEPER THAT THE OPPOSITE ONE. THIS CAN SUGGEST ABOUT INCORRECTLY PLACED ROD IN THE SCREW TULIP BEFORE TIGHTENING. IN ADDITION, THE SHAPE OF THE OBSERVED DEFORMATIONS IS COMMON FOR THE SITUATION WHEN ROD IS NOT SUFFICIENTLY ENGAGED INTO SCREW TULIP. THE FIRST THREAD IS DEFORMED. SUCH DEFORMATION COULD HAVE OCCURRED AS A RESULT OF MISALIGNMENT OF BLOCKER WITH SCREW TULIP DURING ITS INSERTION. TWO BLOCKERS FOUND IN PACKAGING MARKED "CROSS THREADING DAMAGED BLOCKERS": FIRST THREADS OF BOTH BLOCKERS ARE DAMAGED. HOWEVER, ON BOTH BLOCKERS ONE CAN OBSERVE THE IMPRINTS OF A ROD ON THE BOTTOM SURFACES. IT MEANS THAT DESPITE THE CROSS THREADING, BOTH OF THEM WERE DRIVEN INTO THE SCREW TULIP AND TRIED TO BE TIGHTENED. THE WALLS OF HEXAGONAL INTERFACE OF BOTH BLOCKERS ARE NOT DAMAGED. DEVICE HISTORY REVIEW: NO NON CONFORMITIES OR DEVIATIONS LINKED WITH REPORTED EVENT WERE NOTED DURING MANUFACTURING PROCESS. COMPLAINT HISTORY: IN TOTAL BLOCKER CROSS THREADING OF BLOCKER DEFORMATION ISSUE IS CONFIRMED IN 16 OF THE 24 COMPLAINTS IN A TOTAL OF 25 UNITS. RISK ANALYSIS: THE POTENTIAL EFFECT "BLOCKER FAILS OR TULIP/SCREW BECOMES COMPROMISED OR TULIP SEPARATES FROM SCREW OR TULIP COULD BECOME SPLAYED" OF FAILURE MODE "DOES NOT LOOK AT ARROWS DURING FINAL TIGHTENING" AT FINAL TIGHTENING STEP OF SURGERY IS TAKEN INTO ACCOUNT IN CURRENT A FMEA WITH OCCURRENCE 7 AND CORRESPONDING SEVERITY 7/S2. CONCLUSION: THREE BLOCKERS WERE RECEIVED FOR INVESTIGATION. AT VISUAL INSPECTION DAMAGE OF FIRST THREAD FROM BOTTOM SIDE (CROSS THREADING) WAS CONFIRMED FOR ALL BLOCKERS. IN ADDITION, THE DEFORMATION OF BOTTOM SIDE (RESULT OF FINAL TIGHTENING) WAS ALSO OBSERVED ON ALL THREE BLOCKERS. HOWEVER, ON ALL THREE BLOCKERS THIS DEFORMATION IS NOT WELL DEFINED. IT CAN SIGNIFY THAT THE TIGHTENING WAS NOT PERFORMED UNTIL 12NM OR THAT THE ROD WAS NOT WELL INSTALLED INTO TULIP OF CORRESPONDING SCREW OR WAS ACUTE BENT. THE CROSS THREADING TYPICALLY RESULTS FROM MISALIGNMENT OF BLOCKER DURING ITS INSERTION AND TIGHTENING. IN ADDITION, ONE OF THE FOLLOWING ROD POSITIONS IN THE SCREW TULIP CAN ALSO LEAD TO THE CROSS THREADING AND BLOCKER DAMAGE: THE ROD IS NOT HORIZONTALLY PLACED INTO THE SCREW HEAD. THE ROD IS HIGH IN THE SCREW HEAD. AN ACUTE CONVEX OR CONCAVE BEND IS CONTOURED INTO THE ROD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DURING XIA3 SURGERY, 2 BLOCKER WORN. WHEN THE FINAL TIGHTENING OF LEFT S2AI SCREW, THE SURGEON HEARD A STRANGE SOUND. BECAUSE IT SEEMED CROSSING THREAD, HE CHANGED TO OTHER BLOCKER AND DID THE FINAL TIGHTENING. THEN WHEN THE FINAL TIGHTENING OF RIGHT S1 SCREW, THE SURGEON HEARD A STRANGE SOUND AGAIN. BECAUSE THE BLOCKER CONTINUED WEARING, HE CHANGED TO OTHER SCREW AND BLOCKER. FINALLY HE COULD DO THE FINAL TIGHTENING OF ALL SCREWS."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DURING XIA3 SURGERY, 2 BLOCKER WORN. WHEN THE FINAL TIGHTENING OF LEFT S2AI SCREW, THE SURGEON HEARD A STRANGE SOUND. BECAUSE IT SEEMED CROSSING THREAD, HE CHANGED TO OTHER BLOCKER AND DID THE FINAL TIGHTENING. THEN WHEN THE FINAL TIGHTENING OF RIGHT S1 SCREW, THE SURGEON HEARD A STRANGE SOUND AGAIN. BECAUSE THE BLOCKER CONTINUED WEARING, HE CHANGED TO OTHER SCREW AND BLOCKER. FINALLY HE COULD DO THE FINAL TIGHTENING OF ALL SCREWS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48851 XIA 3 TITANIUM BLOCKER IMPLANT KWP STRYKER SPINE-SWITZERLAND M3S

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 35 MM