
Synthes landed in more hot water with the FDA, after the watchdog agency tagged it for violations at its West Chester, Pa., headquarters, including failing to promptly investigate and report complaints about potentially malfunctioning devices.
In a warning letter sent Feb. 16 to Synthes president & CEO Michael Orsinger, the FDA chided Synthes for improperly handling customer complaints related to Click’X surgical screws and N-Hance surgical rods.
"We will cooperate and work diligently with the FDA until these deficiencies are fully resolved," company spokesman Gilgian Eisner told the Philadelphia Inquirer.
Synthes received complaints that surgeons were having difficulty seating surgical heads onto pedical screws in March 2010 and began reworking units that were held in inventory at a Colorado distribution center, according to the letter, but did not include lots that had already been sent to consultants or customers. The screw systems were the cause of more complaints in May 2010, according to the warning letter.
The agency also noted that an October 2008 audit of the company’s device history record revealed that one lot of N-Fix II surgical rods deemed "non-conforming" was distributed commercially without review. Synthes recalled 2 years’ worth of the product in November 2008.
Additional agency review found that some complaint reports were never investigated at all, some never received follow-up and other were not reported to the FDA within the designated 30-day window, including 1 complaint submitted to the agency 2 years after Synthes received it.
Complaints included a surgeon’s January 2010 report of a broken N-Hance surgical rod, which had to be surgically removed from a patient, and an April 2011 complaint that the rod "had defaulted or fell apart." Synthes had submitted reports in both of those cases, but failed to provide follow-up reports in a timely manner, according to the FDA warning.
It’s more bad news for the device giant, which recently saw 4 former executives land prison time for their parts in unauthorized bone cement trials that left 3 patients dead. The families of those patients filed a lawsuit against Synthes for wrongful death and elder abuse earlier this month.
The company is also in the middle of a $23.1 billion buyout by health care giant Johnson & Johnson (NYSE:JNJ), a deal which is still under review by the European Commission.