BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIPER2 FINAL TIGHTENER HANDLE

    MDR report key: 4101381 · Received September 19, 2014

    Report

    Report Number
    1526439-2014-11908
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    January 6, 2014
    Report Date
    March 25, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE VIPER2 FINAL TIGHTENER HANDLE FOUND NO APPARENT DAMAGE ON THE HANDLE. EXAMINATION FOND THE HANDLE WAS SEIZED AND DID NOT LIMIT TORQUE. THE INSTRUMENT WAS DISASSEMBLED AND EXAMINATION FOUND THE INTERNAL GEAR HAD FRACTURED INTO TWO PIECES, MOST LIKELY RESULTING IN FINAL TIGHTENER HANDLE SEIZURE. REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DISCREPANCIES. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE BEEN ATTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. A 12 MONTH COMPLAINT TREND ANALYSIS WAS CONDUCTED ON THE INDIVIDUAL PRODUCT CODE FOUND NO EMERGING TRENDS. THE ROOT CAUSE FOR THE VIPER2 FINAL TIGHTENER HANDLE BEING SEIZED CAN BE ATTRIBUTED TO THE FRACTURED GEAR. HOWEVER, THE CAUSE OF THE GEAR FRACTURE CANNOT BE POSITIVELY DETERMINED. NO CORRECTIVE ACTION/PREVENTIVE ACTION IS REQUIRED AT THIS POINT AS THERE HAS BEEN NO ISSUES IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THIS DEVICE AND THERE HAS BEEN NO SYSTEMATIC TREND. THEREFORE, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. 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 DURING THE FINAL TIGHTENING OF THE VIPER SET SCREW AT THE L4, THE DISTAL TIP OF THE VIPER2 FINAL TIGHTENER DRIVER BROKE OFF AND WAS FLUSH INSIDE THE SET SCREW; A COUNTER TORQUE STABILIZER HAD BEEN USED. THE BROKEN TIP WAS LEFT IN PLACE WITHIN THE SET SCREW TO COMPLETE THE PROCEDURE. MFG. MEDWATCH REPORT NO. 1526439-2014-11051 HAD BEEN SUBMITTED FOR THE VIPER2 FINAL TIGHTENER DRIVER WHICH EXPERIENCED TIP BREAKAGE DURING THE EVENT. THE VIPER2 FINAL TIGHTENER HANDLE, 286745500, THAT WAS USED DURING THE EVENT WAS IDENTIFIED AS A CONCOMITANT DEVICE ON THE SUBMITTED MEDWATCH REPORT. HOWEVER, FURTHER REVIEW OF THE PRODUCT COMPLAINT AND INVESTIGATION RESULTS FOUND THE INVESTIGATION OF THE COMPLAINT ON MAR-25-2014 HAD DETERMINED THAT THE VIPER2 FINAL TIGHTENER HANDLE, HAD SIEZED AND DRIVER TIP BREAKAGE HAD BEEN ATTRIBUTED TO THE SIEZING OF THE VIPER2 FINAL TIGHTENER HANDLE. THIS MFG MEDWATCH REPORT NO. 1526439-2014-11908 IS BEING FILED FOR THE VIPER2 FINAL TIGHTENER HANDLE WHICH HAD SEIZED AND TO WHICH BREAKAGE OF THE VIPER2 FINAL TIGHTENER DRIVER HAS BEEN ATTRIBUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582742 VIPER2 FINAL TIGHTENER HANDLE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SYNTHES SPINE GB34025

    Patients

    Seq Age Sex Outcome Treatment
    1