BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMPERION

    MDR report key: 2863257 · Received December 10, 2012

    Report

    Report Number
    1020279-2012-00666
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 7, 2012
    Manufacturer
    BROOKS MANUFACTURING SITE
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE INSTRUMENT TIP FRACTURED AND WAS LEFT IN THE PATIENT'S FEMUR CANAL. THE SURGEON DID NOT ATTEMPT TO RETRIEVE THE SMALL TIP IN THE FEMUR CANAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMPERION SLEEVE REMOVAL TOOL MEH BROOKS MANUFACTURING SITE 08JSY0006

    Patients

    Seq Age Sex Outcome Treatment
    1