Events

Recall of Screw Inserter for TFN-Advanced (TFNA) Proximal Femoral Nailing System

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-01090-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-11-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01090-1
  • 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
    Upon evaluation, depuy synthes discovered that certain lots of the screw inserter may potentially be etched with an incorrect graphic. the orientation of the etched image of the oblique angle on the screw inserter may be reversed which does not correspond to the tip of the angle of the instrument. this could result in the oblique cut at the lateral end of the screw being at a 90 degree angle to the lateral cortex.It is possible that the user would identify the final lateral oblique angle is not in the desired position, which could result in repositioning the screw within the nail so that the oblique angle of the screw is flush with the bone. the screw is designed to go in either orientation to allow proper depth placement of screw which is a critical factor for the success of the implant.
  • Action
    JJM is requesting users inspect all devices in their possession and to quarantine all non-conforming stock prior to their return to JJM. This action has been closed-out on 29/08/2016.

Device

Screw Inserter for TFN-Advanced (TFNA) Proximal Femoral Nailing System
  • Model / Serial
    Screw Inserter for TFN-Advanced (TFNA) Proximal Femoral Nailing SystemPart number: 03.037.025Lot Numbers: 8911887, 8911975, 9166356, 9285766, 9286671, 9319408, 9375245, 9375251, 9388359, 9388360, 9393071, 9393074, 9393075, 9393076, 9409795, 9409796, 9422892, 9422895, 9498455, 9310899, 9310900, 9319407ARTG Number: 153950
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes