BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD, FIXATION, INTRAMEDULLARY

    MDR report key: 4150798 · Received October 8, 2014

    Report

    Report Number
    2520274-2014-13956
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    July 14, 2014
    Report Date
    September 11, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN (B)(4) ANTEGRADE FEMORAL NAIL/UNKNOWN LOT. (B)(4). DEVICE HAS NOT BEEN REPORTED TO HAVE BEEN EXPLANTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT AN ANTEGRADE FEMORAL NAIL JAPANESE WAS USED FOR A FRACTURE OF SHAFT OF FEMUR CASE. THE END CAP COULD NOT BE INSERTED INTO THE NAIL AT ALL DURING THE SURGERY. ALTHOUGH THE SURGEON ADDED SURGICAL INCISION TO CONFIRM THE NAIL DID NOT GET CAUGHT IN PATIENT¿S SOFT TISSUE, HE WAS NOT ABLE TO INSERT THE END CAP. THE SURGEON TRIED TO INSERT THE OTHER END CAP BUT WITHOUT SUCCESS. FINALLY HE DECIDED NOT TO INSERT AN END CAP AND COMPLETED THE SURGERY. THE SURGERY WAS EXTENDED FOR SIXTY MINUTES DUE TO THIS EVENT. THIS REPORT IS FOR AN UNKNOWN (B)(4) ANTEGRADE FEMORAL NAIL. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632397 ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention