For years, doctors have believed that permanent metal ties are the best way to bind sternum incisions following open heart surgery, because in addition to sealing the wounds, they provide needed pressure. So, for almost as long, medical device makers have been aching to offer a product in this market. The problem is that these kinds of devices are very intricate and delicate, especially considering the fact that today’s post-surgical patients are usually not in good health and not able to tolerate anything excessively harsh.
DePuy Synthes—a division of Johnson & Johnson— thought it had the answer with its Sternal ZipFix System. Unfortunately for those patients that had this device implanted in their sternums, this pronouncement assumed that all component parts of the ZipFix System worked properly. Nevertheless, the Food and Drug Administration approved the product in 2012, through the expedited 510(k) process. In 2015, DePuy Synthes voluntarily recalled the dangerous device’s application instrument, but not before hundreds of people were seriously injured.
When medical gadget makers, or any other product manufacturers, put profits before people, the aggressive attorneys at Napoli Shkolnik PLLC stand up for victims. Our experienced lawyers use proven methods to hold companies responsible for the lives they endanger through the reckless pursuit of profits, and that means maximum compensation for victims.
Issues with the ZipFix
This dangerous product consists of medical-grade stainless steel zip ties and an application device that resembles a staple gun. The FDA, aware of the device’s potential based on the success of similar devices, quickly approved the ZipFix System.
Shortly thereafter, inspectors determined that the device had a number of defects that could lead to serious injuries. For example,
- Simply by squeezing the tensioner trigger to secure the zip ties, it was possible to actually sever the device.
- The end cap easily broke off during routine procedures, a serious product defect that rendered the device completely useless.
- Pivotal screws could detach, causing either the nut or the spring to drop into the thoracic cavity, triggering severe tissue damage and possible organ failure.
DePuySynthes told the FDA that it had addressed the problems and there was no need for further action, but the problems persisted, and the agency issued a Class 2 product recall on the application instrument.
Many times, especially if the product maker is in a hurry to get their product to market, the manufacturer takes dangerous shortcuts during the assembly process, trims the quality control budget, or both. As a result, errors occur, these errors are not caught, and unsuspecting people are injured.
Tenacious Attorneys That Make A Difference
The rushed 510(k) approval process is usually a red flag, because the FDA often rubber-stamps devices that follow this avenue. That outcome is obviously the case with the ZipFix System. If a doctor used this device on you or a loved one and serious injury resulted, call the experienced New York personal injury attorneys at Napoli Law today for a free consultation, because you have a limited amount of time to act.