Events

Safety Alert for Attachment for Acetabular and Medullary Reaming

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
    2015-11-12
  • Event Date Posted
    2015-11-12
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151112.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 attachment for acetabular and medullary reaming the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning the attachment for acetabular and medullary reaming, manufactured by depuy synthes. the product is used with the compact air drive ii, an air-driven power tool for use in traumatology, endoprosthetics and spinal column surgery. the affected product number is 511.785 and the affected serial numbers include 16384,16385,16386,16387,16389,16390,16391,16392,16393, 16394,16395,16396,16397,16403,16405 and 16411. according to the manufacturer, the geometrical shape of a subcomponent of this attachment was inadvertently changed. this change allows potential unintended reverse (counter-clockwise) motion if the subcomponent is aligned in a specific orientation when the attachment is connected to the handpiece and both triggers are pressed. this attachment is intended to be used without reverse motion. unintentional activation in reverse could potentially damage flexible drilling or reaming shafts and could potentially cause serious injury to the patient. the manufacturer advises customers to return the affected products. for details, please refer to the tga website:http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2015-rn-01094-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 12 november 2015.

Device

Attachment for Acetabular and Medullary Reaming
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Depuy Synthes Attachment for Acetabular and Medullary Reaming
  • Manufacturer
    Depuy Synthes

Manufacturer

Depuy Synthes