Orthopedic implant device maker, Stryker Corporation, just announced that its Instruments division received a U.S. Food and Drug Administration (FDA) warning letter prompted by observations the agency made during a November 2012 inspection of one of Stryker’s Portage, Michigan locations.
The letter discusses quality system observations made during the inspection and cites Stryker for neglecting to advise the agency of a product recall. The letter also discusses that Stryker marketed devices, such as the Neptune Waste Management System, without mandated 510(k) clearance. Stryker noted that the FDA letter noted that Stryker Instruments submitted corrective action plans for the quality system and recall observations and that it is fully cooperating with the FDA to resolve these matters.
Stryker did not indicate which of its Portage facilities was inspected by the FDA or which product was recalled, said Reuters. The Neptune product line and some Stryker hip implant products were involved in a series of 2012 Stryker recalls. In fact, the Neptune recall was deemed a Class I, the FDA’s most serious recall designation and involving situations in which there is a reasonable probability that use of the recalled product will lead to serious adverse health consequences or death.
The Neptune Waste Management System is meant to collect and dispose of surgical fluid waste from the patient during procedures in operating rooms and surgical facilities. In September, said Dow Jones Newswire, Stryker said it was expanding a recall it implemented for some specific Neptune Waste Management System models. At that time, Stryker noted that the devices never received mandated FDA clearance.
Stryker Corp. was forced to issue a recall on three models of its Neptune Waste Management Systems after receiving two reports of malfunctions that caused two serious patient injuries, which included one death. In one of the incidents, a patient’s passive chest drainage tube was connected to the Neptune 2 system, a model that features a strong vacuum and high flow. The patient’s death followed surgical complications caused by the malfunctioning Neptune device.
The Class I designation and recall expansion updated a prior Stryker announcement concerning defects and malfunctions with the Neptune systems. According to a previous Bloomberg News report, the initial Stryker communication indicated “that devices should not be connected to passive drainage tubes,” and that the warning was not included on then-current device safety labeling. In the updated recall statement from Stryker, customers were only first told that the Neptune 1 Silver and two versions Neptune 2 Ultra had never been approved for use by the FDA. At that time, Stryker admitted that the FDA did not consider the Neptune waste removal systems to be safe or effective because the agency had not approved the system for use during surgeries.
Prior to a medical device or other pharmaceutical product being released to the market, the manufacturer must have it undergo extensive clinical testing to ensure its safety and efficacy. The FDA then must review these studies for accuracy and potential conflicts-of-interest prior to granting approval for the device’s release to market. Medical devices approved through a fast-track process known as the 510(k) do not require the formal safety and efficacy review that involves human trials. Approval is, rather, obtained by proving the device is similar to an already-approved product. Because the 510(k) route has been used to gain clearance for other controversial products, such as metal-on-metal hip implants and transvaginal mesh devices, the process has drawn increasing criticism.
Due to a lack of required approval, Stryker ceased marketing and distributing the Neptune devices. An alternative device should be sought and, if that’s not available, a certificate of medical necessity must be obtained from the FDA to continue using the device despite the lack of an approval.