Medical device manufacturer, Synthes GmbH, has issued a field safety notice concerning Soft Tissue Retractor, small, extendible with part number 325.101.
Synthes received complaints about tip breakage/locking nut malfunction. Retrieval of device fragments intraoperatively and delayed surgical procedure have been reported as a result of locking nut malfunction.
Unretrieved device fragments may result in an adverse tissue reaction, complaint events have been reported that required the removal of generated device fragments. No known adverse tissue reactions have been reported due to the presence of unretrieved device fragments.
Surgical delays have been reported due to device failure and the resulting time required for retrieving the device fragments. Besides, the sudden loss of function, intraoperative breakage, of the soft tissue retractor has the potential to result in soft tissue irritation.
According to the local supplier, the affected devices were distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 08 May 2013