BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTINCT FINAL SCREWDRIVER SHAFT

    MDR report key: 2852671 · Received November 14, 2012

    Report

    Report Number
    3003853072-2012-00025
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 15, 2012
    Manufacturer
    ZIMMER SPINE
    Product Code
    LXH
    PMA / PMN Number
    K111301
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS EXPECTED TO BE RETURNED BUT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REVISION SURGERY TO EXTEND THE CONSTRUCT, THE TIP OF A DRIVER BROKE OFF AND REMAINS IN THE PT. THE SURGEON WAS ATTEMPTING TO UNLOCK THE BLOCKER OF THE POLYAXIAL SCREW WHEN THE TIP OF THE FIRST DRIVER TWISTED. A SECOND DRIVER WAS USED AND THE TIP OF THIS DRIVER BROKE OFF IN THE BLOCKER. THE SURGEON WAS UNABLE TO REMOVE THE BLOCKER OR THE TIP OF THE DRIVER. THE EXTENSION OF THE CONSTRUCT WAS NOT PERFORMED ON THE LEFT SIDE DUE TO THIS EVENT BUT WAS ABLE TO BE PERFORMED ON THE RIGHT SIDE OF THE CONSTRUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSTINCT FINAL SCREWDRIVER SHAFT INSTINCT FINAL SCREWDRIVER SHAFT LXH ZIMMER SPINE 046W1AN00640 A1507316A

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR