BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIPER2 X-TAB POLYAXIAL DRIVER

    MDR report key: 2801538 · Received October 23, 2012

    Report

    Report Number
    1526439-2012-00223
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Report Date
    April 22, 2013
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY SPINE HAS REQUESTED RETURN OF THE DRIVER FOR EVALUATION. A FOLLOW UP REPORT WILL BE FILED UPON RECEIPT OF THE DEVICE AND COMPLETION OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    THE VIPER2 X-TAB POLYAXIAL DRIVER IS NOT AVAILABLE FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DISCREPANCIES AND CONFIRMED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. WITHOUT A PRODUCT SAMPLE, WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. HOWEVER, IT SHOULD BE NOTED THAT A CAPA WAS OPENED TO ADDRESS PREVIOUS PRODUCT COMPLAINTS INVOLVING DRIVER TIP BREAKAGE. THIS PRODUCTION LOT WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THE CAPA. IN THE ABSENCE OF A PRODUCT SAMPLE, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF THE COMPLAINT PRODUCT SAMPLE BECOMES AVAILABLE, THE COMPLAINT FILE WILL BE RE-OPENED AND THE PRODUCT EVALUATED.

    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.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THE INSPECTION OF A RETURNED LOANER KIT FOUND THE TIP OF THE DRIVER HAD BROKEN OFF FROM THE INSTRUMENT. THE BROKEN TIP WAS NOT PRESENT WITHIN THE KIT. IT IS NOT KNOWN WHEN OR WHERE TIP BREAKAGE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIPER2 X-TAB POLYAXIAL DRIVER INSTRUMENT, ORTHOAPEDIC, MANUAL, SURGICAL LXH DEPUY RAYNHAM MI19233

    Patients

    Seq Age Sex Outcome Treatment
    1