Events

Alerte De Sécurité sur TFN-ADVANCED Proximal Femoral Nailing System

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Synthes GmbH.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2015-04-27
  • Date de publication de l'événement
    2015-04-27
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150427a.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: synthes gmbh tfn-advanced proximal femoral nailing system medical device manufacturer, synthes gmbh, has issued a medical device safety alert concerning its tfn-advanced proximal femoral nailing system (tfna). according to the manufacturer, there is the potential that the tfna nails received before march 31, 2015 from the affected lots were assembled with a locking mechanism too close to the top of the nail. the locking mechanism could:- prevent the connecting screw from fully tightening the insertion handle to the nail resulting in a loose or toggling nail in the insertion handle, or  cause the bottom of the connecting screw to tighten against the top of the locking mechanism preventing advancement of the locking mechanism. if the affected nails were inadequately assembled, there is the potential of surgical delay. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 27 april 2015.

Device

TFN-ADVANCED Proximal Femoral Nailing System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Synthes GmbH TFN-ADVANCED Proximal Femoral Nailing System
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH