BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIPER 2 5MM SELF DRILLING TAP, CANNULATED AND DUAL LEAD

    MDR report key: 2901995 · Received January 8, 2013

    Report

    Report Number
    1526439-2013-10592
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 10, 2012
    Report Date
    January 11, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    NO DEFINITIVE CONCLUSIONS CAN BE MADE HOWEVER IT WAS NOTED THAT THE TAP WAS BEING DRIVEN THROUGH EXTREMELY SCLEROTIC BONE AT THE TIME OF BREAKAGE. THE DESCRIBED NATURE OF THE PATIENT'S EXTREMELY SCLEROTIC BONE LIKELY PRESENTED A HIGHER THAN ANTICIPATED TORQUE DURING TAPPING THUS RESULTING IN TAP FRACTURE. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT WHILE TAPING INTO EXTREMELY SCLEROTIC BONE, THE TIP OF THE VIPER 2 SELF DRILLING CANNULATED TAP BROKE OFF FROM THE INSTRUMENT. THE BROKEN TIP REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8967 VIPER 2 5MM SELF DRILLING TAP, CANNULATED AND DUAL LEAD ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SYNTHES SPINE 0610NG

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR