Events

Safety Alert for Dynamic Locking Screw Stardrive

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

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
    2013-06-14
  • Event Date Posted
    2013-06-14
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130614b.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 dynamic locking screw stardrive medical device manufacturer, synthes, has issued a medical device safety alert concerning certain lots of the dynamic locking screw stardrive ø 3.7mm, self-tapping, cobalt-chrome alloy (cocrmo), sterile [length 22mm to 70mm] and ø 5.0 mm, self-tapping, cobalt-chrome alloy (cocrmo),sterile [length 32mm to 90mm]. the manufacturer received several complaints and investigations showed breakage at the bottom of the pin of the dynamic locking screw (dls). the breakages are recognized during planned implant removal of the whole construct after successful healing. there is the potential that the breakage of a dls may result in a mal-union or non-union requiring additional medical intervention. in a worst case scenario there is the potential for permanent impairment to occur in the presence of a mal-union or non-union. serious injury described as soft tissue damage/irritation and prolonged surgical procedures have been reported as a result of dls breakage. however, no known events of permanent impairment have been reported due to the breakage of a dls. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 14 june 2013.

Device

Dynamic Locking Screw Stardrive
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Synthes Dynamic Locking Screw Stardrive
  • Manufacturer
    Synthes

Manufacturer

Synthes