BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LONG SCREWDRIVER WITH T-HANDLE FOR CLICK'X® LOCKING CAP

    MDR report key: 3831713 · Received May 26, 2014

    Report

    Report Number
    3003875359-2014-10140
    Event Type
    Malfunction
    Date Received
    May 26, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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: A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THE LONG SCREWDRIVER WITH T-HANDLE (388.365) WAS RECEIVED WITH ONE SIDE OF THE DRIVER TIP TWISTED TORSIONALLY. THE ASSOCIATED DRAWINGS WERE REVIEWED. THESE DRAWINGS DETAIL THE APPROPRIATE DIMENSIONS, MATERIALS, AND FINISHING PROCESSES FOR A SUCCESSFUL IMPLANT COUPLING. THIS DEVICE WAS MANUFACTURED JANUARY 10, 2013 TO THE CURRENT DRAWING REVISIONS. THE TONGS OF THE DRIVER ARE DESIGNED TO FIT FIRMLY INTO THE SLOTS OF THE LOCKING CAP. THE LOCKING CAP AND SCREWDRIVER ARE INSERTED THROUGH THE ROD PUSHER AND WHILE THE LOCKING CAP IS TIGHTENED, THE ROD PUSHER IS USED TO COUNTERACT THE TORQUE. ONE OF THE PRONGS WAS TWISTED ON THE RETURNED DRIVER, INDICATING THAT THE DRIVER MAY NOT HAVE BEEN FULLY SEATED WHILE BEING TURNED IN THE LOCKING CAP. THIS WOULD CAUSE THE TORQUE TO BE DISTRIBUTED TO JUST ONE PRONG AND PRODUCE STRESS IN THAT PRONG THAT EXCEEDS THE MATERIAL¿S YIELD STRESS AND THEREFORE PERMANENTLY DEFORM. THERE ARE STRONGER MATERIALS WHICH COULD BE USED TO MANUFACTURE THIS DEVICE; ALTHOUGH IT IS UNKNOWN AS TO IF THESE MATERIALS HAVE A YIELD STRENGTH GREATER THAN THE STRESS RESULTING FROM THE TORQUE ONLY BEING DISTRIBUTED TO ONE PRONG. THE CONDITION OF THE RETURNED INSTRUMENT, AS ONLY ONE OF THE PRONGS IS TWISTED, SUGGESTS THAT THE DRIVER WAS NOT FULLY SEATED WHICH ULTIMATELY RESULTED IN THE COMPLAINT CONDITION. STRONGER STAINLESS STEELS COULD BE USED HOWEVER IT IS UNKNOWN IF THE STRONGER STEELS COULD PREVENT THE PRONG TIP FROM BEING TWISTED WHILE THE DRIVER IS NOT FULLY SEATED. THIS COMPLAINT IS CONFIRMED. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. : NO NONCONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 THAT A PATIENT HAD REVISION SURGERY DUE TO A ROD THAT BROKE BETWEEN L5-S1 ON BOTH SIDES DUE TO PSEUDOARTHROSIS. THE ROD BREAKAGE WAS DISCOVERED DURING A VISIT TO THE SURGEON THROUGH MAGNETIC RESONANCE IMAGING (MRI). DURING THE SURGERY, THE CAPS WERE REMOVED AND THE BROKEN ROD WAS REMOVED, ONE LOOSE SCREW WAS REPLACED. THE RODS WERE REPLACED WITH TITANIUM ALUMINUM NIOBIUM (TAN) RODS AND NEW CAPS WERE PLACED. A FINAL TIGHTENING TORQUE WRENCH WAS USED TO FINAL TIGHTEN ALL THE CAPS. A CAGE WAS PLACED THROUGH THE L5-S1 DISC SPACE. A TRANS-CONNECTOR WAS PLACED BETWEEN L5-S1 SCREWS. IT WAS ALSO REPORTED THAT SEVERAL INSTRUMENTS WERE DAMAGED DURING THE BROKEN ROD REVISION SURGERY AND SEVERAL INSTRUMENT TIPS BROKE OFF. THE SCREWS AND TIPS WERE REMOVED FROM THE CAPS OF THE DEVICES, SOME TIPS LANDED IN THE CAPS, AND PATIENT WITH NO HARM TO THE PATIENT. NO PATIENT HARM WAS REPORTED DURING THE REVISION SURGERY. A TIME DELAY OF 15 MINUTES WAS REPORTED. IT WAS REPORTED THE INSTRUMENTS MAY HAVE BEEN DAMAGED DURING THE PROCESS DUE TO THE DIFFICULT ANGLE OF THE L5-S1 SLOPE. THIS IS REPORT 3 OF 11 FOR (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309985 LONG SCREWDRIVER WITH T-HANDLE FOR CLICK'X® LOCKING CAP SCREWDRIVERS HXX SYNTHES HAGENDORF 8238430

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR