Events

Safety Alert for TFN-ADVANCED Proximal Femoral Nailing System

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Synthes GmbH.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2015-04-27
  • Event Date Posted
    2015-04-27
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150427a.html
  • Notes / Alerts
    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.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    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
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Synthes GmbH TFN-ADVANCED Proximal Femoral Nailing System
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH