Medical device manufacturer, Zimmer, has issued a medical device safety alert concerning Tibial Alignment Guide – iAssist Knee System. The affected device is identified as follows:-
Based upon complaint investigation, the manufacturer has determined that the potential exists for the spikes on the iAssist Tibial Alignment Guide to bend or break during insertion or extraction from the tibia during use. The bending or breakage of the spikes is due to a stress riser at the junction of the spike and the main body of the instrument in combination with the presence of repeated high cyclic bending stresses from the impaction method utilised. These stresses are significantly increased when the proper steps of the surgical technique are not followed.
If a spike breaks and goes unobserved, there is the possibility of a spike being left in the surgical site, which may result in a biocompatibility reaction (17-4PH Stainless Steel not assessed for long term biocompatibility) or interference with Magnetic resonance imaging (MRI), because of the magnetic stainless steel.
The manufacturer is currently making preparations for repair or replacement.
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 22 May 2015