Events

Safety Alert for Trochanteric Fixation Nail Advanced (TFNA) guide sleeve, yellow

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Depuy 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
    2016-06-24
  • Event Date Posted
    2016-06-24
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160624b.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: depuy synthes trochanteric fixation nail advanced (tfna) guide sleeve, yellow medical device manufacturer, depuy synthes, has issued a field safety notice (fsn) concerning its trochanteric fixation nail advanced (tfna) guide sleeve, yellow. the affected part number is 03.037.017. the manufacturer has identified that the some lots of the guide sleeves may have been manufactured with a slightly larger than specified outer diameter which could prevent the sleeve from going through the tfna aiming arm properly. only guide sleeves that do not pass function testing will be removed from the field following the evaluation for functionality of the aiming arms and guide sleeve described in the fsn. in the event that guide sleeve does not fit through the tfna aiming arm properly, a surgical delay may occur. the manufacturer is advising users to take the following actions: to review the inventory to identify and quarantine all affected products in a manner that ensures the affected products will not be used. conduct functional testing and ensure every aiming arm is tested with every guide sleeve within the user’s control. return any affected product that does not pass functional testing to the manufacturer. according to the local supplier, johnson and johnson, two lots of the affected product (lot numbers: 9066435, 9356941) are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 24 june 2016.

Device

Trochanteric Fixation Nail Advanced (TFNA) guide sleeve, yellow
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Depuy Synthes Trochanteric Fixation Nail Advanced (TFNA) guide sleeve, yellow
  • Manufacturer
    Depuy Synthes

Manufacturer

Depuy Synthes