BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD, FIXATION, INTRAMEDULLARY

    MDR report key: 3830081 · Received May 23, 2014

    Report

    Report Number
    2520274-2014-11600
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 6, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THIS REPORT IS FOR ONE UNKNOWN PROXIMAL FEMORAL NAIL ANTIROTATION NAIL/UNKNOWN LOT. THE ORIGINAL IMPLANT DATE WAS IN 2012. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE EXTRACTION OF PROXIMAL FEMORAL NAIL ANTIROTATION BLADE THE LOCKING MECHANISM DIDN¿T OPEN PROPERLY SO THE BLADE WAS EXTRACTED LOCKED WHICH LEFT A LARGE BONE DEFECT THAT HAD TO BE FILLED WITH BONE-SUBSTITUTE. THE TIME FOR THE SURGERY WAS CLEARLY PROLONGED BUT IT IS UNKNOWN THE EXACT AMOUNT OF TIME IT WAS PROLONGED FOR. THE ORIGINAL IMPLANT DATE WAS IN 2012. THIS REPORT IS FOR ONE UNKNOWN PROXIMAL FEMORAL NAIL ANTIROTATION NAIL. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308496 ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention