Events

Safety Alert for Soft Tissue Retractor, small, extendible

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
    2013-05-08
  • Event Date Posted
    2013-05-08
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130508d.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 soft tissue retractor, small, extendible medical device manufacturer, synthes gmbh, has issued a field safety notice concerning soft tissue retractor, small, extendible with part number 325.101. synthes received complaints about tip breakage/locking nut malfunction. retrieval of device fragments intraoperatively and delayed surgical procedure have been reported as a result of locking nut malfunction. unretrieved device fragments may result in an adverse tissue reaction, complaint events have been reported that required the removal of generated device fragments. no known adverse tissue reactions have been reported due to the presence of unretrieved device fragments. surgical delays have been reported due to device failure and the resulting time required for retrieving the device fragments. besides, the sudden loss of function, intraoperative breakage, of the soft tissue retractor has the potential to result in soft tissue irritation. according to the local supplier, the affected devices were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 08 may 2013.

Device

Soft Tissue Retractor, small, extendible
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Synthes Soft Tissue Retractor, small, extendible
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH