Events

Avis De Sécurité sur Trochanteric Fixation Nail (TFN), Titanium Alloy

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Synthes GmbH.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2013-09-27
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    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