BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-STANDARD

    MDR report key: 3082238 · Received April 29, 2013

    Report

    Report Number
    1719045-2013-10977
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    November 3, 2011
    Report Date
    November 3, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    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. 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. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. THE PRODUCT DEVELOPMENT EVALUATION REVEALED THAT ALL SIX OF THE LOBES OF THE RETURNED DEVICE ARE BROKEN OFF UP TO APPROXIMATELY 0.5MM FROM THE DRIVE TIP END. THERE IS NO OTHER VISUALLY OBVIOUS DAMAGE TO THE DEVICE. 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. BASED ON THE DETAILS OF THE COMPLAINT CONDITION AND EVALUATION OF THE RETURNED PART, THERE IS NO INDICATION OF A DESIGN RELATED ISSUE. EVALUATION OF THE DESIGN INDICATES THAT IT IS ACCEPTABLE FOR THE INTENDED USE, THEREFORE 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. ADDITIONAL INFORMATION: FEMALE, PATIENT AGE AT TIME OF EVENT WAS GIVEN AS APPROXIMATELY (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A POSTERIOR LUMBAR INTERBODY FUSION (PLIF) L3-S1 PROCEDURE, AS THE SURGEON WAS REDUCING THE (03.620.091) HEX DRIVE ADAPTER BROKE OFF INSIDE (03.632.008) THE THREADED PERSUADER; THE SURGEON USED 4 DIFFERENT STARDRIVE SCREWDRIVER SHAFTS (03.632.004), (03.632.002), (03.632.072 - X2) TO REMOVE A CAP AND ALL THREE SCREWDRIVER SHAFTS BECAME STRIPPED. THE CAP WAS LEFT IN PLACE, AND IT REMAINS IN THE PATIENT. THE SURGEON INTENDED TO REMOVE THE CAP AT S1 ALLOWING HIM TO THE ROD AND CONTOUR IT; HOWEVER, THE SURGEON WAS ABLE TO GET THE ROD TO CONTOUR AS THE OTHER CAPS WERE LOCKED DOWN. THIS IS REPORT 3 OF 6 FOR THE SAME EVENT. SYNTHES COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185122 T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-STANDARD HXX SYNTHES MONUMENT 6457233

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention