BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAL IMPLANT LARGE DEEP-5MM

    MDR report key: 3822029 · Received May 20, 2014

    Report

    Report Number
    9680938-2014-10021
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HWT
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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. THE RAW MATERIAL WHICH WAS DELIVERED AS LOT #00031910 AND #0031910 IS CORRESPONDING TO THE SPECIFICATIONS. THE HARDNESS WAS MEASURED AT THE TIME OF THE MANUFACTURING AND WAS FOUND TO BE ACCEPTABLE. NO NONCONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 TRIAL WAS RETURNED WITH THE ADJUSTING ROD BROKEN. THE TRIAL ALSO HAD A FEW SCRATCHES NEAR THE THREADED HOLE. ONE LARGE, DEEP, 5MM TRIAL IMPLANT (PART 03.820.055 LOT T923058) WAS RETURNED FOR THE SHAFT REPORTEDLY BREAKING. THE ADJUSTING ROD OF THE TRIAL CONNECTS TO THE 03.820.000 TRIAL HANDLE WHICH ALLOWS THE SURGEON TO DETERMINE THE PROPER HEIGHT, WIDTH, AND DEPTH OF THE PRODISC-C IMPLANT. TRIAL 03.820.055 CORRESPONDS TO IMPLANT 09.820.055S (ALSO LARGE, DEEP, 5MM). PRODUCT DRAWINGS WERE REVIEWED DURING THE INVESTIGATION. THE TRIAL IS DESIGNED WITH THE ADJUSTING ROD CONNECTED TO TRIAL STOPS TO ALLOW THE SURGEON TO ADVANCE THE TRIAL BODY DEEPER INTO THE DISC SPACE TO ENSURE PROPER POSTERIOR PLACEMENT OF THE IMPLANT. BEFORE TRIALING, THE USER ROTATES THE HANDLE CLOCKWISE UNTIL THE STOPS ARE FULLY SEATED AND CANNOT ADVANCE ANY FURTHER. THE TRIAL IS THEN INSERTED INTO THE DISC SPACE AND THE HANDLE IS TURNED COUNTERCLOCKWISE, ADVANCING THE TRIAL 0.5MM FOR REACH FULL ROTATION, UNTIL THE TRIAL IS AT THE POSTERIOR MARGIN OF THE VERTEBRAL BODIES. THE TRIAL WAS RETURNED WITH THE STOPS FULLY SEATED AND THE COMPLAINT DESCRIPTION NOTES THAT THE HANDLE WAS TURNED THE WRONG WAY WHEN THE ADJUSTING ROD BROKE. ROTATING THE HANDLE CLOCKWISE WITH THE STOPS ALREADY FULLY ADVANCED CREATED EXCESSIVE TORQUE AND STRESS ABOVE THE ULTIMATE TENSILE STRENGTH OF THE MATERIAL. THE ADJUSTING ROD IS MANUFACTURED USING H900 TREATED 465 STAINLESS STEEL AND IS FOUND TO BE ADEQUATE FOR THE INSTRUMENTS USE AS THE COMPONENT IS NOT INTENDED TO BE SUBJECTED TO LARGE AMOUNTS OF STRESS. THE DIMENSIONS, TOLERANCES, NOTES AND FINISHING PROCESS WERE ALL FOUND TO BE ADEQUATE FOR THE INSTRUMENT¿S USE AS WELL. THE HANDLE CONNECTED TO THE ADJUSTING ROD WAS ROTATED CLOCKWISE WHILE THE STOPS WERE ALREADY FULLY SEATED. THIS LED TO EXCESSIVE TORQUE BEING APPLIED AND CAUSED THE ROD TO BREAK. THE DESIGN WAS REVIEWED AND FOUND TO BE ADEQUATE FOR THE INSTRUMENT¿S 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 THAT THE SURGEON WAS PERFORMING AN INITIAL CERVICAL DISC ARTHROPLASTY PRODISC-C PROCEDURE AT LEVELS C5-6 AND WHILE LOOSENING THE HANDLE, THE SURGEON TURNED THE TRIAL IMPLANT THE WRONG WAY AND THE DEVICE BROKE AT THE SHAFT. THERE WAS NO PATIENT ADVERSE EVENT AND NO DELAY IN SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300516 TRIAL IMPLANT LARGE DEEP-5MM TEMPLATE HWT SYNTHES TUTTLINGEN T923058

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR