BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIPER2 PEDICLE PREP CANNULA

    MDR report key: 4243678 · Received November 11, 2014

    Report

    Report Number
    1526439-2014-12080
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 17, 2014
    Report Date
    October 17, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VIPER2 PEDICLE PREP CANNULA WAS RETURNED TO THE COMPLAINTS HANDLING UNIT (CHU) FOR EVALUATION. THE CANNULA APPEARS TO BE IN GOOD CONDITION FROM A GENERAL STANDPOINT, AS IT SHOWS SIGNS OF USE BUT LITTLE IN THE WAY OF DAMAGE. ITS BODY IS INTACT AND THE TEETH OF THE PART AT THE SUPERIOR END ARE NOT DAMAGED. HOWEVER, THE INFERIOR TIP OF THE INSTRUMENT SHOWS SIGNS OF WEAR. THE EDGE IS ROUNDED AND LIPPED WITH TWO AREAS IN WHICH A SMALL PLASTIC PIECE MAY HAVE FLAKED OFF. THE ROUGH, SLIGHTLY CHIPPED SURFACE OF THE INSTRUMENT APPEARS TO HAVE OCCURRED AFTER REPEATED USES OF THE INSTRUMENT OR SIMPLY DURING PROCEDURE IN WHICH UNANTICIPATED FORCES WERE APPLIED TO THE CANNULA, RESULTING IN VISIBLE WEAR. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED. NO ISSUES WERE IDENTIFIED IN THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. A 12 MONTH REVIEW OF THE COMPLAINT TREND ANALYSIS FOR THE VIPER2 PEDICLE PREP CANNULA WAS PERFORMED ON ITS SPECIFIC PRODUCT CODE AS NO FAMILY EXISTS FOR THIS INSTRUMENT. NO EMERGING TRENDS WERE NOTED. THEREFORE, NO FURTHER TRENDING ACTION WILL BE TAKEN AS A PART OF THIS COMPLAINT FILE. THE ROOT CAUSE CANNOT BE DETERMINED FROM THE SAMPLE AND THE INFORMATION PROVIDED. A POTENTIAL ROOT CAUSE WOULD BE UNEXPECTED FORCES APPLIED TO THE SHEATH DURING PEDICLE TAPPING, POTENTIALLY OVER NUMEROUS REPEATED USES. SINCE NO ISSUES HAVE BEEN IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS HAVE BEEN OBSERVED. THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE SURGEON WAS PERFORMING A ONE LEVEL MINIMALLY INVASIVE SURGERY (MIS) FUSION, THE TIP OF THE VIPER2 PEDICLE PREP CANNULA¿S BLACK SLEEVE BECAME CRACKED AND CHIPPED. THE DIFFICULTY DID NOT RESULT IN ANY ADVERSE CONSEQUENCES TO THE PATIENT AND THERE WAS NO DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726694 VIPER2 PEDICLE PREP CANNULA ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SYNTHES SPINE PG215388

    Patients

    Seq Age Sex Outcome Treatment
    1