Events

Safety Alert for Hexagonal Socket, Ø 4.0mm/11.0mm

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
    2015-08-07
  • Event Date Posted
    2015-08-07
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150807_b.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 hexagonal socket, ø 4.0mm/11.0mm medical device manufacturer, synthes gmbh, has issued a medical device safety alert concerning its hexagonal socket, ø 4.0mm/11.0mm [part number: 356.714; lot number: all]. the manufacturer is initiating a voluntary medical device recall of the above mentioned part and lot numbers of the depuy synthes hexagonal socket, ø 4.0mm/11.0mm. the socket is a cannulated instrument used to insert the end caps in the following nail systems: proximal femoral nail anti-rotation (pfna), pfna-ii, and the antegrade femoral nail (afn). there is a potential for the socket-hex tip to break into fragments during use if too much force is applied. breakage of the hex tip may result in surgical delay and an adverse tissue reaction. as the affected item has been reported to break intra-operatively, there is potential for surgical delay while the fragments are retrieved. consequently, surgical delay may occur while a replacement instrument or alternative device is located to insert the end cap. in addition, an adverse tissue reaction may possibly occur if any stainless steel fragments from the socket are not retrieved from the patient. 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 07 august 2015.

Device

Hexagonal Socket, Ø 4.0mm/11.0mm
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Synthes GmbH Hexagonal Socket, Ø 4.0mm/11.0mm
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH