Medical device manufacturer, Synthes GmbH, has issued a medical device safety alert concerning its TFN-ADVANCED Proximal Femoral Nailing System (TFNA).

According to the manufacturer, there is the potential that the TFNA nails received before March 31, 2015 from the affected lots were assembled with a locking mechanism too close to the top of the nail.

The locking mechanism could:-

• Prevent the connecting screw from fully tightening the insertion handle to the nail resulting in a loose or toggling nail in the insertion handle, or
• Cause the bottom of the connecting screw to tighten against the top of the locking mechanism preventing advancement of the locking mechanism.

If the affected nails were inadequately assembled, there is the potential of surgical delay.

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 27 April 2015