BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIPER2 SET SCREW INSERTER, SELF-RETAINING

    MDR report key: 2151194 · Received June 21, 2011

    Report

    Report Number
    1526439-2011-00108
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 19, 2011
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE INSERTERS FOUND TIP BREAKAGE OCCURRED AT THE BASE OF THE FLUTES ON EACH INSTRUMENT. REVIEW OF THE DEVICE HISTORY RECORD FOUND THE LOT OF 266 UNITS MET SPECIFICATION REQUIREMENTS WHEN RELEASED TO STOCK. NO DEFINITIVE CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF TIP BREAKAGE. HOWEVER, THE DAMAGE IS INDICATIVE OF THE APPLICATION OF ATYPICAL FORCE DURING SET SCREW TIGHTENING AND/OR MATERIAL FATIGUE FROM USAGE OVER TIME. THE INSTRUMENTS HAVE BEEN IN SERVICE FOR APPROXIMATELY THREE YEARS. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT THE TIPS OF TWO VIPER2 SET SCREW INSERTERS, BOTH FROM LOT X0508, BROKE OFF WHILE INSERTING SET SCREWS DURING SPINAL SURGERY. THE BROKEN TIPS BECAME EMBEDDED WITHIN THE SET SCREWS AND COULD NOT BE REMOVED AS THE SET SCREWS WERE LOCKED IN PLACE. THERE WAS NO DELAY TO SURGERY AS ANOTHER INSERTER WAS AVAILABLE. IT WAS REPORTED THAT THE SURGEON IS CONFIDENT THAT NO ADVERSE OUTCOMES WILL OCCUR. AS UNINTENDED PORTIONS OF THE INSERTERS REMAIN IN THE PATIENT, THIS MEDWATCH REPORT IS BEING SUBMITTED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIPER2 SET SCREW INSERTER, SELF-RETAINING INSTRUMENT, ORTHOPAEDIC, MANUAL, SURGICAL LXH DEPUY SPINE, INC. NA X0508

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK