BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T25 STARDRIVE SHAFT F/MATRIX

    MDR report key: 3003392 · Received February 28, 2013

    Report

    Report Number
    1719045-2013-10277
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    April 12, 2011
    Report Date
    April 28, 2011
    Manufacturer
    SYNTHES (USA) MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. SUBJECT DEVICE HAS BEEN RECEIVED AND EVALUATED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE SUPPLIER'S CERTIFICATIONS INDICATE THAT THE CORRECT MATERIAL WAS USED AND THE CORRECT HARDNESS VALUES WERE OBTAINED. THE SHAFT WAS RETURNED WITH THE STARDRIVE FORM ROUNDED ALONG THE EDGES AND ALL BUT ONE LOBE BROKE OFF. THE BREAK WAS APPROXIMATELY 1MM FROM THE TIP. THE SHAFT HAD AXIAL SCRATCHES THAT WERE CONSISTENT WITH USE. CERTIFICATION INDICATES THIS PRODUCT WAS MANUFACTURED TO PRODUCT DRAWING. THE DIMENSIONS MEASURED WERE FOUND TO BE WITHIN PRINT SPECIFICATION EXCEPT FOR THE STARDRIVE DEPTH BECAUSE THE TIP WAS BROKEN. TIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT BECAUSE THE DAMAGED PORTION OF THE PRODUCT MAKES PHYSICAL DIMENSIONAL VERIFICATION IMPOSSIBLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SCOLIOSIS SURGERY, THE SURGEON TRIED TO LOOSEN A MATRIX LOCKING CAP AFTER FINAL TIGHTENING USING THE MATRIX T25 STARDRIVE SHAFT, LONG AND THE PANGEA TORQUE LIMITING HANDLE. THE SURGEON ATTEMPTED LOOSENING WITH THE SAME SCREWDRIVER/TORQUE HANDLE AND COUNTERTORQUE AS PER THE TECHNIQUE GUIDE AND THE SCREWDRIVER TIP BROKE. ALL PIECES OF THE BROKEN SCREWDRIVER WERE REMOVED AND THE SURGEON ATTEMPTED LOOSENING AGAIN WITH ANOTHER MATRIX T25 STARDRIVE SHAFT, LONG, PANGEA TORQUE LIMITING HANDLE WITH COUNTERTORQUE AND THE SECOND SCREWDRIVER TIP BROKE. ALL FRAGMENTS WERE REMOVED AND THE SURGEON ATTEMPTED LOOSENING AGAIN WITH MATRIX T25 STARDRIVE SHAFT, STANDARD, PANGEA TORQUE LIMITING HANDLE WITHOUT UTILIZING THE COUNTERTORQUE TECHNIQUE AS RECOMMENDED IN THE PRODUCT TECHNIQUE GUIDE. UPON TRYING TO LOOSEN IN THE CAP, THE SCREWDRIVER SHAFT BROKE AND SLIPPED CAUSING INJURY TO THE PATIENT'S SPINAL CORD. THE PATIENT EXPERIENCED A DURAL TEAR, WHICH WAS REPAIRED. AFTER SURGERY THE PATIENT EXPERIENCED A PARTIAL TEMPORARY LOSS OF LEG MOVEMENT, BUT RECOVERED 36 HOURS AFTER THE SURGERY. A TOTAL OF 3 MATRIX STARDRIVE SHAFTS WERE USED DURING THE PROCEDURE. THE TIP ON THE FIRST SHAFT BROKE OFF AND WAS RETRIEVED. THE TIP ON THE SECOND SHAFT ALSO BROKE AND WAS RETRIEVED. THE THIRD SHAFT SLIPPED AND CAUSED INJURY TO THE SPINAL CORD. THE EVENT WITH THE 1ST AND 2ND SHAFT WAS UNRELATED TO THE 3RD SHAFT THAT CAUSED THE SPINAL CORD INJURY. THIS IS REPORT 1 OF 2 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86941 T25 STARDRIVE SHAFT F/MATRIX HXX SYNTHES (USA) MONUMENT 6413848

    Patients

    Seq Age Sex Outcome Treatment
    1