BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIPER2 X-TAB CANNULATED POLYAXIAL SCREWDRIVER

    MDR report key: 3072553 · Received April 23, 2013

    Report

    Report Number
    1526439-2013-15723
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 22, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    HWR
    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 COMPLETION OF THE INVESTIGATION.

    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. NO DEFINITIVE CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF TIP BREAKAGE. HOWEVER, A CAPA WAS IMPLEMENTED WHICH ADDRESSED TIP BREAKAGE THROUGH DESIGN MODIFICATION AND MATERIAL CHANGE. TESTING ON PRODUCTION LEVEL INSTRUMENTS HAD DETERMINED THAT TIP BREAKAGE WAS THE RESULT OF A BRITTLE FRACTURE OF THE MATERIAL. THIS PRODUCTION LOT WAS MANUFACTURED PRIOR TO THOSE CHANGES. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT INSPECTION OF A RETURNED LOANER KIT FOUND THE TIP OF THE POLYAXIAL DRIVER HAD BROKEN OFF FROM THE INSTRUMENT. IT IS NOT KNOWN WHEN/WHERE TIP BREAKAGE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174772 VIPER2 X-TAB CANNULATED POLYAXIAL SCREWDRIVER DRIVER, PROSTHESIS HWR DEPUY SYNTHES SPINE MI19980

    Patients

    Seq Age Sex Outcome Treatment
    1