BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T25 STARDRIVE SHAFT F/MATRIX STANDARD

    MDR report key: 3080582 · Received April 26, 2013

    Report

    Report Number
    1719045-2013-10836
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    September 14, 2011
    Report Date
    September 14, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE SCREWDRIVER SHAFT WAS RECEIVED FOR A MANUFACTURING INVESTIGATION WITH THE STARDRIVE TIP BROKEN INTO 4 DETACHED SECTIONS. ABRASIONS WERE VISIBLE ABOUT THE HEX COUPLING SURFACE. THE ETCH DETAIL WAS COMPLETE, BUT DETERIORATED. THE STARDRIVE TIP WAS HEAVILY DAMAGED. THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING STANDPOINT DUE TO THE DAMAGE SUSTAINED TO THE STARDRIVE TIP. SPECIFICATIONS OF THIS FUNCTIONAL FEATURE COULD NOT BE OBTAINED DUE TO DAMAGE. A PRODUCT DEVELOPMENT EVENT EVALUATION WAS ALSO PERFORMED. THE MATRIX TECHNIQUE GUIDE DESCRIBES A SPECIFIC PROCEDURE FOR LOOSENING AND REMOVING LOCKING CAPS. THIS TECHNIQUE ENSURES THAT THE DRIVER TIP IS NEVER SUBJECTED TO TORQUE BEYOND THE MAXIMUM THAT THE TORQUE LIMITING HANDLE CAN DELIVER. THE YIELD TORQUE OF A MATRIX T25 SHAFT IS WELL ABOVE THIS LIMIT, WHICH ENSURES THAT THE SHAFT WILL NOT SEE A TORQUE HIGH ENOUGH TO YIELD OR BREAK IT IF THE TECHNIQUE IS FOLLOWED CORRECTLY. MECHANICAL TESTING HAS SHOWN THAT T25 DRIVERS CONSTRUCTED OF X15 MATERIAL WHEN FULLY INSERTED INTO THE RECESS CAN DELIVER TORQUES IN EXCESS OF 14.5NM WITHOUT DAMAGE. BASED ON THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DETERMINE THE ACTUAL CAUSE OF THE BROKEN SCREWDRIVER. IT IS POSSIBLE THAT THE REMOVAL TECHNIQUE WAS NOT FOLLOWED CORRECTLY AND A NON-TORQUE LIMITING HANDLE WAS USED INSTEAD. THIS COULD POTENTIALLY EXPOSE THE SHAFT TO MORE THAN 12NM DEPENDING ON HOW MUCH TORQUE THE SURGEON TRIED TO APPLY. ANOTHER POSSIBLE CAUSE OF EXCESSIVE TORQUE IS A FAULTY 10NM TORQUE LIMITING HANDLE. THE TORQUE HANDLE USED IN THE EVENT WAS NOT RETURNED WITH THE STARDRIVE SHAFT SO IT IS NOT POSSIBLE TO EVALUATE THIS. THEREFORE, THIS COMPLAINT IS INDETERMINATE FROM A DESIGN STANDPOINT.

    Additional Manufacturer Narrative · 1

    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.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A POSTERIOR LUMBAR INTERBODY FUSION PROCEDURE, THE SURGEON WAS TRYING TO REMOVE A LOCKING CAP USING A MATRIX SCREWDRIVER SHAFT WHEN THE TIP OF THE SHAFT BROKE OFF. THE SURGEON USED ANOTHER OF THE SAME TYPE OF DRIVER TO COMPLETE THE PROCEDURE WITH NO ADVERSE EFFECT ON THE PATIENT. THIS REPORT IS FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183098 T25 STARDRIVE SHAFT F/MATRIX STANDARD HXX SYNTHES MONUMENT 6495447

    Patients

    Seq Age Sex Outcome Treatment
    1