Medical device maker Synthes Inc. has been officially warned by federal regulators over procedures by which it receives complaints on defective medical devices.
The West Chester, Pa., company has just over two weeks to correct those issues and report how it plans to implement better procedure to the Food and Drug Administration (FDA) or the agency could be compelled to take further action against the company.
Synthes manufactures plates and rods used in reconstructing bones, most often used in trauma situations like following major traffic accidents. In its warning letter received from the FDA in February, Synthes is accused of failing to properly follow-up on complaints about certain rods it manufactures. The company also failed multiple times at reporting device malfunctions to the FDA within the 30-day window it has.
Synthes recently made headlines late last year when a judge in Pennsylvania sentenced four of its former executives to prison terms for their role in illegally promoting Norian bone cement. Three deaths have been attributed to the use of Norian when used in back surgeries.
The company, and its executives, were found guilty of conducting their own “clinical trial” of Norian for use in back surgeries without clearance from the FDA. The judge in the case accused the Synthes execs of conducting “human experimentation” in the pursuit of profit for their company. Each received prison sentences because of their direct involvement with the experimentation.
Norian was approved for use in arms but not in the spine. The company was accused of including more than 50 surgeons to be part of its illegal marketing campaign of the bone cement.
According to a Dow Jones report, the medical trauma segment of the devices industry is one of the fastest-growing. Synthes is in the process of being purchased by industry giant Johnson & Johnson for $21.3 billion.
The same report indicates Synthes received its warning letter on Feb. 16, meaning the 15-day time frame it had to report back to the FDA with its changes to the complaint procedures has passed.
Medical device makers are required to report any complications or complaints about its products to the FDA in a timely manner. It is also required to follow-up with every credible complaint waged against one of its products. A failure to do so can result in untold serious injuries and deaths to future recipients of a potentially dangerous medical device.