Events

Recall of Optimys Opening Broach Bent (Reusable surgical instrument used for opening the medullary canal)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Mathys Orthopaedics 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-2013-RN-01020-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-10-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01020-1
  • 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
    Mathys ltd bettlach has been notified of an incident in switzerland where the optimys opening broach broke intraoperatively and the fragment was left in the bone. in the course of the investigations, it became apparent that the opening broach bent may exhibit surface defects in the hewn portion which may favour breakage in case of non-compliant usage.
  • Action
    Replacement products made of more suitable material are being manufactured and will be provided to customers as soon as they become available. In the interim, customers are reminded on the correct usage of the device according to the surgical technique.

Device

Optimys Opening Broach Bent (Reusable surgical instrument used for opening the medullary canal)
  • Model / Serial
    Optimys Opening Broach Bent (Reusable surgical instrument used for opening the medullary canal)Article Number: 51.34.0079Lot Number: 6054883ARTG Number: 184413
  • Manufacturer
    Mathys Orthopaedics Pty Ltd

Manufacturer

Mathys Orthopaedics Pty Ltd