BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIPER POLYAXIAL SCREWWDRIVER SHAFT, CANNULTD

    MDR report key: 3162610 · Received June 11, 2013

    Report

    Report Number
    1526439-2013-18606
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION NOTED THAT THE FRACTURE OF THE VIPER POLYAXIAL DRIVER OCCURRED AT THE DRIVER¿S DISTAL TIP. NO OTHER DEFECTS OR ABNORMALITIES WERE OBSERVED DURING EVALUATION OF PRODUCT. A SCANNING ELECTRON MICROSCOPY ANALYSIS WAS PERFORMED ON THE FRACTURED SURFACES TO FACILITATE A MORE DETAILED INVESTIGATION OF THE FRACTURE CHARACTERISTICS OF THE RETURNED DAMAGED SAMPLE. ALTHOUGH NO DEFINITIVE CONCLUSIONS CAN BE MADE, RESULTS SUGGEST THAT THE POLYAXIAL SCREW DRIVER UNDERWENT A QUASI-STATIC OVERLOAD FAILURE. NO MATERIAL DEFECTS OR OTHER ABNORMALITIES WERE OBSERVED IN THIS ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD FOUND 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 REVIEW OF THE COMPLAINT TREND ANALYSIS FOUND NO OBSERVED TRENDS FOR ISSUES OF THIS NATURE. IN THE ABSENCE OF AN IDENTIFIED DEVICE MANUFACTURING/RELEASE ISSUE OR OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT INSPECTION OF A RETURNED LOAN KIT FOUND THE DISTAL TIP HAD BROKE OFF FROM THE POLYAXIAL SCREWDRIVER SHAFT. IT IS NOT KNOWN WHEN OR WHERE TIP BREAKAGE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263372 VIPER POLYAXIAL SCREWWDRIVER SHAFT, CANNULTD ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SYNTHES SPINE U10611

    Patients

    Seq Age Sex Outcome Treatment
    1