Hong Kong’s Medical Device Control Office said Johnson & Johnson‘s (NYSE:JNJ) Synthes division issued a warning about the risk of injury from 1 of its soft tissue retractors.
Synthes, for which J&J paid nearly $20 billion last year, said it received several reports of "tip breakage and locking nut malfunctions," according to the Hong Kong safety watchdog.
"Retrieval of device fragments intraoperatively and delayed surgical procedure have been reported as a result of locking nut malfunction," according to the warning. "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," the Hong Kong MDCO said.