Events

Recall of Ankle Arthrodesis Nail 611AFN Drill Bit

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Tornier Pty Ltd.

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-2017-RN-00680-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-06-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00680-1
  • 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
    Despite being guided by drill reference mju775, cases of drill breakage during surgery have been received by wright medical australia. this issue has been replicated by the manufacturer in internal tests. breakage of the tip of the drill during use may lead to the need to remove debris and a delay in surgery.
  • Action
    Wright Medical is advising users that in order to optimize the drilling technique, there will be a modification to the cutting edge of the drill. Users will be contacted for the return and exchange when replacements become available (from November 2017). In the interim, users are advised to apply the drilling force in the axis of the drill (as illustrated in the recall notification).

Device

Ankle Arthrodesis Nail 611AFN Drill Bit
  • Model / Serial
    Ankle Arthrodesis Nail 611AFNDrill Bit Model Number: MJU777Lot Numbers 11D463 and 12E794ARTG Number: 112287
  • Manufacturer
    Tornier Pty Ltd

Manufacturer

Tornier Pty Ltd