BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIPER2 X-TAB POLYAXIAL SCREW DRIVER

    MDR report key: 2896608 · Received January 4, 2013

    Report

    Report Number
    1526439-2013-10252
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 17, 2012
    Report Date
    February 5, 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

    VISUAL EXAMINATION OF THE RETURNED DRIVER FOUND THAT THE MOST DISTAL PORTION OF THE TIP HAD BROKEN OFF FROM THE INSTRUMENT. REVIEW OF DEVICE HISTORY RECORDS CONFIRMED THE INSTRUMENT WAS MANUFACTURED TO SPECIFICATION REQUIREMENTS. A CAPA THAT ADDRESSED TIP BREAKAGE THROUGH DESIGN MODIFICATION AND MATERIAL CHANGE HAS BEEN IMPLEMENTED. THIS PRODUCT LOT WAS MANUFACTURED PRIOR TO THOSE CHANGES. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS RETURNED LOAN KIT INSPECTION FOUND THE TIPS OF THREE VIPER2 X-TAB POLYAXIAL SCREWDRIVERS HAD BROKEN OFF FROM THE INSTRUMENTS. IT IS NOT KNOWN WHEN/WHERE TIP BREAKAGE OCCURRED. THIS REPORT IS FOR ONE DRIVER, CATALOG# 286760010, LOT MI20049 SEE MFG MEDWATCH REPORT# 1526439-2013-10244 FOR THE OTHER TWO DRIVERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4171 VIPER2 X-TAB POLYAXIAL SCREW DRIVER ORTHOPEDIC, MANUAL SURGICAL INSTRUMENT LXH DEPUY SYNTHES SPINE MI20049

    Patients

    Seq Age Sex Outcome Treatment
    1