BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT TIP T25 DRIVER-LONG

    MDR report key: 3880799 · Received June 18, 2014

    Report

    Report Number
    3003875359-2014-10177
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: AN EVALUATION WAS PERFORMED ON THE RETURNED DEVICE. AS PER RECEIVED CONDITION OF DEVICE SHOWS THAT THE STRAIGHT TIP T25 DRIVER-LONG WAS RECEIVED WITH A FRACTURED DISTAL TIP WHICH WAS NOT RETURNED. THE STRAIGHT TIP T25 DRIVER LONG IS A COMPONENT OF THE MATRIX DEGENERATIVE AND DEFORMITY SYSTEM. THE MATRIX SPINE SYSTEM DEGENERATIVE IS A COMPREHENSIVE THORACOLUMBAR PEDICLE SCREW SYSTEM DESIGNED TO PROVIDE FLEXIBILITY, BIOMECHANICAL PERFORMANCE AND A TOTAL SOLUTION TO COMPLEX POSTERIOR PATHOLOGICAL CHALLENGES. THE T25 DRIVER IS SPECIFICALLY DESIGNED TO BE UTILIZED WITH A 10NM TORQUE LIMITING RATCHET HANDLE AND A COUNTERTORQUE CANNULA TO TIGHTEN AND LOOSEN LOCKING CAPS WHICH SECURE RODS INTO POLYAXIAL AND OR PEDICLE SCREWS. DRAWINGS FOR THE STRAIGHT TIP T25 DRIVER WERE REVIEWED. THE MOST CURRENT REVISION OF THE DRAWING WAS REVIEWED, IN ADDITION THE PREVIOUS REVISION WAS REVIEWED AS THE PART WAS MANUFACTURED UNDER THAT DRAWING. THESE DRAWINGS WERE FOUND SUITABLE TO DETERMINE THE INTENDED DEVICE DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY. THE DRIVER WAS FOUND TO HAVE MET THE DRAWING SPECIFICATIONS. THE PRODUCT WAS RECEIVED UNDER THE COMPLAINT CONDITION BROKEN: TIP BROKEN INTRAOPERATIVELY AND THE PRODUCT WAS RECEIVED WITH A FRACTURED TIP, THE BROKEN-OFF TIP WAS NOT RETURNED. THE COMPLAINT DESCRIPTION MAKES NO MENTION OF THE USE OF A TORQUE LIMITING HANDLE WHICH IS REQUIRED IN THE TECHNIQUE GUIDE. THE APPEARANCE OF THE FRACTURED TIP ON THE RETURNED ITEM MATCHES THE APPEARANCE OF DRIVERS THAT WERE TESTED IN A LABORATORY SETTING AT SYNTHES. THE MECHANICAL TESTING SHOWED THAT MATERIAL YIELDING OCCURRED AT APPROXIMATELY 15 NM AND SHEARING OCCURRED AT APPROXIMATELY 20 NM. THE FRACTURED TIP SUGGESTS THAT THE RETURNED PART WAS SUBJECTED TO TORQUE OF, OR ABOVE, 20 NM. THE TECHNIQUE GUIDE NOTES; TO ENSURE THE SCREWDRIVER SHAFT IS PROTECTED FROM DAMAGE, ALWAYS USE THE 10 NM LIMITING HANDLE. ADDITIONALLY THE GUIDE CAUTIONS: NEVER USE FIXED OR RATCHETING T-HANDLE SCREWDRIVER FOR THIS TECHNIQUE. IF THE TORQUE LIMITING ATTACHMENT IS NOT USED WHEN USING ANY OF THE STARDRIVE SHAFT OPTIONS BREAKAGE OF THE DRIVER MAY OCCUR AND COULD POTENTIALLY HARM THE PATIENT. AS THE RECOMMENDED TORQUE LIMITED HANDLE HAS A 10 NM LIMIT, IT CLEARLY WAS NOT USED, AND THEREFORE THE TECHNIQUE GUIDE WAS NOT FOLLOWED. AS THE COMPLAINT CONDITION RESULTED FROM THE APPLICATION OF EXCESS TORQUE, THE PRODUCT DESIGN DID NOT CONTRIBUTE TO THE PART FAILURE. THE COMPLAINT IS CONFIRMED AS THE PART DID FAIL. AFTER REVIEWING THE RELATED PRODUCT DRAWINGS, COMPLAINT HISTORY AND RISK ANALYSIS, THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE DID FAIL, SO THE COMPLAINT IS CONFIRMED. THE COMPLAINT DESCRIPTION DOES NOT MENTION THE WHICH INSTRUMENTS WERE USED IN AN ASSEMBLY TO REMOVE THE LOCKING CAPS AT THE TIME OF THE PART FAILURE, IF THE TORQUE LIMITING HANDLE HAD BEEN USED, THE FORCE REQUIRED TO BREAK THE DRIVER COULD NOT HAVE BEEN ACHIEVED. THE DEVICE IS DETERMINED TO BE SUITABLE FOR ITS INTENDED USE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING SURGERY, THE TIP OF THE SCREWDRIVER BROKE OFF. ALL PARTS WERE EASILY RETRIEVED AND ALTERNATE SCREW DRIVER WAS USED TO COMPLETE SURGERY SUCCESSFULLY WITH NO DELAY AND NO ADVERSE EFFECT ON THE PATIENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357792 STRAIGHT TIP T25 DRIVER-LONG SCREWDRIVERS HXX SYNTHES HAGENDORF 7614371

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR