Events

Recall of Synthes Small Electric Drive Hand Piece (Drill Surgical System)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Synthes 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-2014-RN-01278-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-12-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01278-1
  • 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
    It has been reported that the small electric drive (sed) may experience failure modes such as the device not functioning, the device operating solely in reverse mode, the device not operating in reverse when intended or an unintended start of the device. this may lead to surgical delays in the event the user requires a replacement power tool. an unintended start of the hand piece or wrong mode/direction could cause bone/soft tissue damage, peripheral nerve damage and /or vascular damage because the hand piece has the potential to progress further into the surgical site when the operator is not intending this motion. these injuries may need surgical or medical intervention.
  • Action
    Affected units are to be quarantined and returned as per the instructions in the Customer Letter. DuPuy Synthes will then provide a replacement at no charge in the form of a Colibri II (532.101) along with an electric adapter (05.001.1058) and a wire driver (532.022) to use instead of the Small Electric Drive. This action has been closed-out on 06/07/2016.

Device

Synthes Small Electric Drive Hand Piece (Drill Surgical System)
  • Model / Serial
    Synthes Small Electric Drive Hand Piece (Drill Surgical System)Part Number: 05.001.175 All Lot NumbersARTG Number: 157072
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd