BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD,FIXATION,INTRAMEDULLARY

    MDR report key: 3883571 · Received June 19, 2014

    Report

    Report Number
    2520274-2014-11947
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THIS REPORT IS FOR ONE UNKNOWN HELICAL BLADE/UNKNOWN LOT.DEVICE HAS NOT BEEN EXPLANTED.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 A MALFUNCTION OCCURRED WITH A TROCHANTERIC FIXATION NAIL BLADE DURING SURGERY. IT WAS REPORTED THE BLADE WOULD NOT ADVANCE ALL THE WAY. THE SURGEON BACKED OUT THE LOCKING MECHANISM ON THE NAIL AND THE ISSUE WAS RESOLVED. THERE WAS REPORTEDLY A THREE TO FIVE MINUTE DELAY IN THE PROCEDURE.THIS REPORT IS FOR ONE HELICAL BLADE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360131 ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1