BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIPER 2 FINAL TIGHTENER SHAFT

    MDR report key: 2823045 · Received November 7, 2012

    Report

    Report Number
    1526439-2012-00256
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Report Date
    December 10, 2012
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSIONS CAN BE MADE AS THE FINAL TIGHTENER DRIVER SHAFT IS NOT AVAILABLE FOR EVALUATION AND ITS LOT CODE IS UNKNOWN. WITHOUT A PRODUCT SAMPLE WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. REVIEW OF MANUFACTURING RECORDS CANNOT BE COMPLETED AS THE DEVICE LOT CODE IS UNKNOWN.AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED. (B)(4): DEVICE NOT AVAILABLE FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE DRIVER WAS RETURNED FOR EVALUATION. NO DEFINITIVE CONCLUSIONS CAN BE MADE. HOWEVER, ANALYSIS OF THE TORQUE DRIVER SHAFT SHOWS EVIDENCE OF A TORSIONAL SHEAR QUASI-STATIC FAILURE STARTING AT THE HEX LOBES AND EXTENDING TOWARDS THE CENTER OF THE SHAFT. THE EXISTENCE OF SEVERAL CRACKS INDICATES THAT BREAKAGE OCCURRED DUE TO HIGH TORSIONAL SHEAR LOADS. NO MATERIAL DEFECTS OR OTHER ABNORMALITIES WERE OBSERVED IN THIS ANALYSIS. SCANNING ELECTRON MICROSCOPY ANALYSIS SUGGESTS THAT THE DRIVER UNDERWENT A STATIC FAILURE DUE TO SHEAR TORSIONAL OVERLOADING WHILE TIGHTENING, WHICH MAY BE ATTRIBUTED TO OVER TORQUING BY THE CONCOMITANT DEVICE TORQUE HANDLE WRENCH. THE TORQUE WRENCH HANDLE WAS NOT RETURNED FOR EVALUATION. COMPLAINT DATA IS REVIEWED MONTHLY BY CROSS FUNCTIONAL GROUPS WITHIN THE COMPANY TO ENSURE A ROBUST REVIEW. COMPLAINT DATA REVIEW FOUND NO EMERGING TRENDS. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT AFTER CORRECT INSERTION OF VIPER2 SCREWS, RODS AND INNIE SET SCREWS, THE DOCTOR PERFORMED FINAL TIGHTENING USING THE VIPER2 FINAL TIGHTENER SHAFT, TORQUE WRENCH HANDLE, AND THE ANTI TORQUE WRENCH. DURING FINAL TIGHTENING, THE TIP OF DRIVER SHAFT BROKE OFF INSIDE ONE OF THE INNIE SET SCREWS. THE BROKEN TIP REMAINS WITHIN THE IMPLANTED INNIE SET SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIPER 2 FINAL TIGHTENER SHAFT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY RAYNHAM AG2093830

    Patients

    Seq Age Sex Outcome Treatment
    1 VIPER2 ANTI TORQUE WRENCH, 286745150| VIPER2 TORQUE WRENCH HANDLE, 286745500