Events

Field Safety Notices about Trochanteric Fixation Nail (TFN), Titanium Alloy

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Synthes GmbH.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2013-09-27
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Extra notes in the data
  • Reason
    Through internal investigation synthes identified the potential for non-conforming helical blades to be distributed to the field. helical blades, which are part of the tfn system, may have one or more dimensional features out of tolerance. the potential features that may be out of tolerance include the inner diameter of the helical blade where the guide wire passes and the dimensional features that allow for the helical blade and insertion instrument to mate. these non-conformances are not immediately apparent and the following is a summary of the potential outcomes that could occur if a patient is exposed to non-conforming product.

Device

Trochanteric Fixation Nail (TFN), Titanium Alloy
  • Model / Serial
    Part Description Part Number Lot Number 456300 - 456.310 & 456,650 5615864 Helical Blade for TFN. itanium Alloy through 456.3003 - 455.3103 3. 7423581 456.6505
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH