Events

Safety Alert for Small Electric Drive

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Synthes GmbH.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2014-12-08
  • Event Date Posted
    2014-12-08
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141208b.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: synthes gmbh small electric drive medical device manufacturer, synthes gmbh, has issued a medical device safety alert concerning its small electric drive [part number: 05.001.175; lot number: all]. according to the manufacturer, 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. if the device is tested in the operative theatre and the unit does not function, a replacement power tool would need to be procured, which may lead to surgical delay. 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. the manufacturer instructs affected users to immediately identify and quarantine all unused products. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 8 december 2014.

Device

Small Electric Drive
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Synthes GmbH Small Electric Drive
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH