Events

Recall of Reamer/Irrigator/Aspirator (RIA)(Medullary canal orthopaedic reamer, flexible)

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-00618-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-07-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00618-1
  • 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
    Depuysynthes reported that the ria drive shaft, tube assembly, and reamer head have the potential to break when incorrectly assembled or used improperly as follows: - failure to fully engage the reamer to shaft at assembly prior to surgery. incorrect assembly creates a reduced reamer/shaft contact surface area, in which excess rotational forces could cause breakage- use of ria drive shafts after the flats have become worn and rounded - use of any excess force beyond design limit - use with an incompatible power tool. precautionary statements are being added to the reamer / irrigator / aspirator (ria) surgical technique guide.
  • Action
    DePuySynthes is requesting the customers to download the updated Surgical Technique Guide (036.000.553). from Synthes website at:- http://syntheskyo.com/global_trauma_kyo/home/home.htm or contact their DePuy Synthes Representative for a hardcopy. This action has been closed-out on 05/12/2016.

Device

Reamer/Irrigator/Aspirator (RIA)(Medullary canal orthopaedic reamer, flexible)

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes