Medical device manufacturer, Synthes GmbH, has issued a field safety notice concerning Aiming Arm 125°for Static Distal Locking (03.037.014) and Aiming Arm 130° for Static Distal Locking (03.037.013), which are a part of the TFN-ADVANCED (TFNA) System. The Aiming Arms are used with various instruments to assist in the proper alignment of TFNA.
Below are the details of the affected lot products:
The manufacturer discovered that during blade insertion, the TFNA Guide Sleeve has the potential to jam inside of the affected Aiming Arms which may delay disassembly and/or removal of the instruments.
The manufacturer advises users to follow the steps mentioned in the field safety notice to address any occurrences of jamming.
The manufacturer is in the process of developing the replacement and recovery plan for indicated devices.
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 11 March 2015