Events

Recall of TPS MicroDriver (used for surgical procedures involving drilling, reaming, driving wires or pins, cutting bone and hard tissue)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Stryker Australia 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-01048-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-10-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01048-1
  • 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
    Two batches of silicone potting have been identified by the supplier as having cure properties that were outside of the specified range. the potting material is used to insulate, stabilise and provide a moisture barrier to the main printed circuit board assembly (pcba) of the tps microdriver. inadequate curing of the silicone potting creates the possibility for silicone potting to leak outside of the handpiece and cause electrical malfunction.
  • Action
    Stryker is requesting users to inspect and quarantine devices from the affected lot numbers. Affected devices are to be returned to Stryker for repair before returning to the customers. Stryker will provide a loan unit to be used until the device is repaired.

Device

TPS MicroDriver (used for surgical procedures involving drilling, reaming, driving wires or pins,...
  • Model / Serial
    TPS MicroDriver (used for surgical procedures involving drilling, reaming, driving wires or pins, cutting bone and hard tissue)Catalogue Number: 5100088000Lot Numbers: 0921700523, 0723606673ARTG Number: 139725
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA