BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAIL, FIAXATION, BONE

    MDR report key: 3884926 · Received June 19, 2014

    Report

    Report Number
    2520274-2014-12022
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    JDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR ONE UNKNOWN NAIL. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. 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 DURING A TROCHANTERIC FIXATION NAIL PROCEDURE, THERE WAS A MALFUNCTION WITH A TROCHANTERIC FIXATION NAIL AND BLADE. THE BLADE WOULD NOT ADVANCE ALL THE WAY WHICH CAUSED A 5 MINUTE DELAY. THE SURGEON HAD TO BACK OUT THE LOCKING MECHANISM ON THE NAIL TO RESOLVE THE ISSUE. THIS REPORT IS FOR ONE UNKNOWN NAIL. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359934 NAIL, FIAXATION, BONE JDS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1