Events

Recall of TFN-ADVANCED Proximal Femoral Nailing System (TFNA)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-00372-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-05-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00372-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Johnson & johnson is initiating a recall for product correction for the depuy synthes tfn-advanced proximal femoral nailing system (tfna). the tfna system is intended for treatment of proximal femoral fractures.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. this problem was due to human error during assembly of the device with the manufacturer and no design changes are required.Therefore 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.The above may lead to delays in surgery with the potential for complications associated with prolonged anaesthesia.
  • Action
    A workaround is being provided for users via the customer letter. This action has been closed-out on 08/08/2016.

Device

TFN-ADVANCED Proximal Femoral Nailing System (TFNA)

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes