BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2861286 · Received October 6, 2012

    Report

    Report Number
    2861286
    Event Type
    Malfunction
    Date Received
    October 6, 2012
    Date of Event
    August 23, 2012
    Report Date
    October 6, 2012
    Manufacturer
    SYNTHES
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WE USED A 4.5MM X 46M CANNULATED SCREW OUT OF THE SYNTHES CANNULATED SCREW SET. ONCE THE SCREW WAS IN PLACE AND AN XRAY WAS PERFORMED, IT WAS NOTED WITH IMAGING THAT THE VERY TIP OF THE SCREW AND THREADS HAD BROKEN OFF. THE SCREW WAS THEN REMOVED, HOWEVER, THE TIP OF THE SCREW REMAINED IN THE PATIENT. THE SCREW WAS REPLACED AND A NEW SCREW FROM A DIFFERENT IMPLANT SET WAS PUT IN. THE OFFENDING SCREW WAS SAVED AND MARKED ALONG WITH AN XRAY IMAGE DISPLAYING THE BROKEN SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SCREW, CANNULATED HWC SYNTHES 4.5MM X 46M *

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR