Events

Recall of Oscillating Saw Attachment for Colibri/Colibri II Small Electric Drive (Battery-driven, cutting power tool system used in surgical procedures such as cutting of bone and hard tissue)

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-00353-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-04-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00353-1
  • 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
    Johnson & johnson medical pty limited (jjm) has received reports that the oscillating saw attachment may disengage intra-operatively. if the device is tested in the operative theatre and the unit does not function, the user most likely would discontinue use of the affected part, and a replacement oscillating saw attachment would be procured, which may lead to surgical delay. injury to the patient can occur if the attachment disengages intra-operatively. there is also a potential of injury to the user from the sharp edge of the subject oscillating saw during retrieval. one report of a serious injury was received where the part fell apart during surgery and resulted in cuts in the hand of a user.
  • Action
    Johnson & Johnson Medical Pty Limited (JJM) is providing instructions to customers for checking for any disassembly of the attachment as part of every reprocessing cycle. If customers notice any disassembly of the attachment or are able to unscrew the attachment as part of the inspection, they are advised to not use it and immediately send it for repair. Devices which perform satisfactorily during the inspection may be used as intended. A review and repair will be implemented if necessary during the next scheduled maintenance inspection at the Service Centre. Customers are also reminded to ensure the devices are sent for maintenance according to the recommended annual schedule.

Device

Oscillating Saw Attachment for Colibri/Colibri II Small Electric Drive (Battery-driven, cutting p...
  • Model / Serial
    Oscillating Saw Attachment for Colibri/Colibri II Small Electric Drive (Battery-driven, cutting power tool system used in surgical procedures such as cutting of bone and hard tissue)Part Number (Saw Attachment): 532.021All Serial NumbersProduct Numbers (Electric Drive): 532.001, 532.010, 532.101, 532.110 and 05.001.175ARTG number: 157072
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes