BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIPER2 FINAL TIGHTENER DRIVER

    MDR report key: 4192675 · Received October 22, 2014

    Report

    Report Number
    1526439-2014-12020
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 23, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. 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

    THE VIPER2 FINAL TIGHTENER DRIVER WAS NOT RETURNED FOR EVALUATION. EXAMINATION OF A PHOTO THAT WAS PROVIDED NOTED THAT THE DISTAL TIP OF THE DRIVER HAD BEEN BROKEN OFF. REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DISCREPANCIES. A REVIEW OF THE COMPLAINT TREND ANALYSIS WAS PERFORMED AND NO SYSTEMIC TREND WAS IDENTIFIED AS A RESULT OF THE ANALYSIS. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS HAVE BEEN OBSERVED, THIS COMPLAINT FILE 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. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    ONE (1) VIPER2 FINAL TIGHTENER DRIVER [PRODUCT CODE: 2867-45-550, LOT NO: AG2093845] WAS RETURNED TO THE COMPLAINTS HANDLING UNIT (CHU) FOR EVALUATION. VISUAL EXAMINATION REVEALED THAT THE FRACTURE WAS LOCATED AT THE DRIVER¿S DISTAL TIP. THE FRACTURED TIP OF THE DRIVER WAS NOT PROVIDED. DEVICE WAS THEN SENT FOR FRACTURE ANALYSIS. THE FRACTURE ANALYSIS REPORT SUGGESTS THE DRIVER UNDERWENT A QUASI-STATIC TORSIONAL SHEAR OVERLOAD FAILURE STARTING AT THE DRIVER HEX AND IS EXTENDED TO THE CENTER OF THE SHAFT, THE POTENTIAL FRACTURE TERMINATION SITE. NO MATERIAL DEFECTS OR OTHER ABNORMALITIES WERE OBSERVED IN THIS ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. A TREND ANALYSIS WAS CONDUCTED. NO EMERGING TRENDS WERE FOUND REQUIRING FURTHER ACTIONS. THE ROOT CAUSE OF THE FINAL TIGHTENER DRIVER TIP BECOMING BROKEN CANNOT POSITIVELY BE DETERMINED. HOWEVER, THE FRACTURE ANALYSIS REPORT SUGGESTS THE DRIVER UNDERWENT A QUASI-STATIC TORSIONAL SHEAR OVERLOAD FAILURE STARTING AT THE DRIVER HEX AND IS EXTENDED TO THE CENTER OF THE SHAFT, THE POTENTIAL FRACTURE TERMINATION SITE. ADDITIONALLY, THE FINAL TIGHTENING HANDLE HAS ALSO BEEN FOUND TO BE SEIZED AND IS ANOTHER CONTRIBUTING FACTOR TO THE FAILURE OF THE FINAL TIGHTENER DRIVER TIP. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS WERE FOUND, THIS COMPLAINT FILE 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

    PER INTERNATIONAL AFFILIATE, THE CUSTOMER REPORTED THAT THE VIPER2 FINAL TIGHTENER HANDLE IS NOT TRIGGERING (IE. STOPPING DURING TORQUE TIGHTENING) BECAUSE THE TIP OF THE VIPER FINAL TIGHTENER DRIVER IS BROKEN. AFFILIATE REPORTS THE TIP OF THE FINAL TIGHTENER SHAFT BROKEN BECAUSE THE HANDLE IS NOT STOPPING. THE BROKEN TIP WAS RETRIEVED BUT WAS LOST DURING THE DECONTAMINATION PROCESS. THE FOLLOWING MFG MEDWATCH REPORTS ARE BEING FILED FOR THE VIPER2 FINAL TIGHTENER HANDLE AND VIPER FINAL TIGHTENER DRIVER THAT WERE INVOLVED IN THIS EVENT. 1526439-2014-12019; 1526439-2014-12020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671087 VIPER2 FINAL TIGHTENER DRIVER SCREWDRIVER HXX DEPUY SYNTHES SPINE AG2093845

    Patients

    Seq Age Sex Outcome Treatment
    1