BEUDAMED
    FDA Adverse Event Injury Summary report: N

    END CAP

    MDR report key: 2872648 · Received December 7, 2012

    Report

    Report Number
    2520274-2012-03724
    Event Type
    Injury
    Date Received
    December 7, 2012
    Report Date
    November 10, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PT WAS IMPLANTED WITH 12MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX, LOCKING SCREWS AND END CAP TO THE LEFT FEMUR ON AN UNK DATE. PT RETURNED FOR A FOLLOW-UP DOCTORS VISIT WITH KNEE PAIN. PT WAS THEN RETURNED TO THE OPERATING ROOM ON (B)(6) 2012 FOR REMOVAL OF HARDWARE. THE NAIL WAS SLIGHTLY STICKING INTO THE KNEE JOINT SUBSEQUENTLY CAUSING PAIN IN THE PT'S KNEE. PT WAS NOT REVISED WITH ANY ADDITIONAL HARDWARE AS THE PT'S FEMUR FRACTURE WAS COMPLETELY HEALED. THE EXPLANT PROCEDURE WAS COMPLETED. SUCCESSFULLY. REPORTEDLY THERE WERE NO DEVICES BROKEN. THIS IS 5 OF 5 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 END CAP JDS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention NAIL| LOCKING SCREWS