BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIPER2 T20 DRIVER, CANNULATED

    MDR report key: 2810266 · Received October 31, 2012

    Report

    Report Number
    1526439-2012-00242
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 1, 2012
    Report Date
    March 1, 2013
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY (B)(4) 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 DRIVER WAS NOT RETURNED FOR EVALUATION. THE INVOLVED LOT NUMBER(S) WAS NOT PROVIDED; WITHOUT A LOT NUMBER, A REVIEW OF MANUFACTURING RECORDS CANNOT BE COMPLETED. COMPLAINT DATA IS REVIEWED MONTHLY BY CROSS FUNCTIONAL GROUPS WITHIN THE COMPANY TO ENSURE A ROBUST REVIEW. COMPLAINT DATA REVIEW FOUND NO EMERGING TRENDS. WITHOUT A PRODUCT SAMPLE WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. IN THE ABSENCE OF A PRODUCT SAMPLE, LOT NUMBER, OR OBSERVED TREND, 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.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THE TIP OF THE DRIVER HAD BROKEN OFF FROM THE INSTRUMENT DURING SCREW INSERTION. ANOTHER DRIVER WAS AVAILABLE TO INSERT THE SCREW AND COMPLETE THE CASE WITH NO DELAY OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIPER2 T20 DRIVER, CANNULATED ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY RAYNHAM

    Patients

    Seq Age Sex Outcome Treatment
    1 VIPER SCREW: CATALOG NUMBER UNKNOWN