Medical device manufacturer, DePuy Synthes, has issued a medical device safety alert concerning all lots of the ATTUNE INTUITION Tibial Articulation Surface Instruments used in trialing with the ATTUNE Knee System.
According to the safety alert, the Balseal, which is a small wire spring coil located on the post feature of the Articulation Surface Instruments, has the potential to become damaged and disassociate (come off). The Balseal is constructed from implant grade stainless steel. If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.
Damage to the Balseal is potentially caused by:
To reduce the possibility of leaving a disassociated Balseal in a patient, the manufacturer advises users to follow the IFU, which include inspecting the ATTUNE Articulation Surface Instruments before, during and after use, to ensure that the Balseals are not damaged and that no instruments or pieces are left in the patient. Balseal disassociation potentially occurs secondary to damage to the Tibial Articulation Surface during removal of the trial from the joint space or reprocessing.
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 19 June 2015