Medical device manufacturer, Synthes GmbH, has issued a medical device safety alert concerning its Epoca Stem Extractors and Connection Screws. The affected devices are identified as follow: -
The manufacturer is initiating a voluntary field safety notification (FSN) for the part and lot numbers of the Epoca Stem Extractors and Connection Screws. There is a potential for the Connection Screw (P/N 03.401.077) of the Stem Extractor (P/N 03.401.072) to break. This breakage could occur during the step 3 "Head/eccenter removal and humeral stem extraction" shown and described on page 10 of the Surgical Technique "Epoca Revision Set" [DSEM/TRM/0714/0131(1)]. "To remove the stem, mount and fully tighten the stem extractor using the hexagonal wrench. Mount the ram/guide bar and apply gentle blows."
According to the manufacturer, if the Stem Extractor breaks, the potential impact to the patient includes surgical delay, bone damage, and/or adverse tissue reaction.
The affected users are asked to review the instructions listed in the FSN.
According to the local supplier, the affected products are not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 28 March 2018