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