BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T25 STARDRIVE SHAFT F/MATRIX LONG

    MDR report key: 3052109 · Received April 11, 2013

    Report

    Report Number
    1719045-2013-10638
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    November 1, 2011
    Report Date
    November 1, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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 SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES PRODUCT DEVELOPMENT EVALUATION REVEALED FIVE OF THE SIX LOBES OF THE RETURNED DEVICE WERE BROKEN OFF UP TO APPROXIMATELY 0.5MM FROM THE DRIVE TIP. THE DRIVE WILL NO LONGER RETAIN A SCREW. THE DESIGN HAS BEEN EVALUATED AND HAS BEEN DETERMINED TO BE ACCEPTABLE FOR THE INTENDED USE. THE MATERIAL OF THE SCREWDRIVER SHAFT IS X15 WHICH IS AN APPROPRIATE MATERIAL FOR AN INSTRUMENT OF THIS TYPE. THE TIP IS A T25 STARDRIVE AND IS DESIGNED TO BE USED WITH THE MATRIX SCREWS AND LOCKING CAPS AND FIT INSIDE THE HOLDING SLEEVES AND OTHER INSTRUMENTATION IN THE SYSTEM. THE DESIGN HAS BEEN DEMONSTRATED, WHEN FULLY INSERTED INTO THE RECESS, TO WITHSTAND TORQUES IN EXCESS OF 14.5 NM WITHOUT DEFORMATION OR BREAKAGE. THE TECHNIQUE GUIDE SPECIFIES THAT FINAL TIGHTENING OF THE LOCKING CAPS SHOULD ONLY BE PERFORMED WITH A CALIBRATED, SYNTHES 10 NM TORQUE HANDLE WITH A CAUTION THAT STATES NEVER USE A FIXED OR RATCHETING T-HANDLE SCREWDRIVER FOR THIS TECHNIQUE. IF THE TORQUE LIMITING ATTACHMENT IS NOT USED, BREAKAGE OF THE DRIVER MAY OCCUR. THE DEFORMATION ON THE TIPS INDICATES THAT THE DRIVER WAS USED FOR LOOSENING AND IT DOES NOT APPEAR FROM THE DAMAGE THAT THE TORQUE LIMITING ATTACHMENT WAS USED AS DIRECTED. BASED ON THE DETAILS OF THE COMPLAINT CONDITION AND EVALUATION OF THE RETURNED PART, THERE IS NO INDICATION OF A DESIGN RELATED ISSUE AND THE COMPLAINT IS DEEMED INVALID.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LUMBAR FUSION PROCEDURE AT L3-L5 THE TIP OF THE HOLDING SLEEVE AND THE TIP OF THE SCREWDRIVER BROKE OFF IN THE HEAD OF A SCREW DURING INSERTION. ALL PIECES WERE REMOVED FROM THE PATIENT. THE SURGEON USED ANOTHER HOLDING SLEEVE, SCREWDRIVER AND A NEW SCREW TO COMPLETE THE PROCEDURE. THIS IS REPORT 1 OF 2 FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 2 FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155421 T25 STARDRIVE SHAFT F/MATRIX LONG HXX SYNTHES MONUMENT 6543878

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR