BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/300MM/RT-STERILE

    MDR report key: 6095551 · Received November 11, 2016

    Report

    Report Number
    2520274-2016-15350
    Event Type
    Injury
    Date Received
    November 11, 2016
    Report Date
    October 15, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    PMA / PMN Number
    K040336
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A 300MM TITANIUM CANNULATED LATERAL ENTRY FEMORAL RECON NAIL, A 6.5MM RECON SCREW, AND FOUR (4) TITANIUM STARDRIVE LOCKING SCREWS ON AN UNKNOWN DATE TO REPAIR A FEMUR FRACTURE. ON AN UNKNOWN DATE, THE PATIENT REPORTED FEELING SOME PAIN AFTER A FALL. UPON EVALUATION, IT WAS DISCOVERED THAT THE FIXATION WAS COLLAPSED AND HAD FAILED. IT WAS CLARIFIED THAT UPON EXAMINATION, IT WAS NOTED THAT THE COMPLAINED DEVICES HAD MIGRATED. ON (B)(6) 2016, THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR A REVISION SURGERY TO REMOVE THE COMPLAINED DEVICES. ALL OF THE DEVICES WERE REMOVED AND FOUND TO BE INTACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTS OF DELAY OR MEDICAL INTERVENTION. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746603 10MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/300MM/RT-STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention