BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T25 STARDRIVE SHAFT F/MATRIX LONG

    MDR report key: 2972285 · Received February 21, 2013

    Report

    Report Number
    1719045-2013-10166
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 4, 2012
    Report Date
    January 4, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED (B)(4) 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. THE PRODUCT DEVELOPMENT EVALUATION VISUAL INSPECTION REVEALED THE STAR DRIVE TIP IS DAMAGED. THREE OF THE SIX LOBES ARE BROKEN OFF UP TO APPROXIMATELY 0.5MM FROM THE DRIVE TIP AND THE REMAINING THREE LOBES ARE ROUNDED OFF. THE DRIVE WILL NO LONGER RETAIN A SCREW. THE DESIGN HAS BEEN EVALUATED AND HAS BEEN DETERMINED TO BE ACCEPTABLE FOR THE INTENDED USE. (B)(4). THE DESIGN HAS BEEN DEMONSTRATED, WHEN FULLY INSERTED INTO THE RECESS, TO WITHSTAND TORQUES IN EXCESS OF (B)(4) 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". 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 CONDITION OF THE RETURNED DEVICE AND THE EVALUATION, THE DESIGN INDICATES THAT IT IS ACCEPTABLE FOR THE INTENDED USE. THEREFORE THE COMPLAINT IS INVALID.

    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 FINAL TIGHTENING OF A L4-S1 FUSION PROCEDURE THE T-25 SCREWDRIVER SHAFT FOR MATRIX BROKE OFF. THE SURGEON RETRIEVED THE PIECES, SELECTED ANOTHER DRIVER AND COMPLETED THE PROCEDURE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76026 T25 STARDRIVE SHAFT F/MATRIX LONG HXX SYNTHES MONUMENT 6573883

    Patients

    Seq Age Sex Outcome Treatment
    1