FDA Warns Nonprofit Device Manufacturer

Surgical Implant Generation Network (SIGN), a manufacturer of intramedullary nails to repair fractured bones, recevied a warning letter from the FDA because it failed to inform the agency when a device broke, forcing patients to undergo surgery.

The nonprofit company, based in Richland, WA, also provides training to surgeons in developing nations.

SIGN was cited for failing to submit medical device reports (MDR) after several instances in which the nails broke or migrated inside the body and had to be surgically removed or replaced, according to the Nov. 18 warning letter.

The FDA also reprimanded the company for failing to establish and maintain procedures for validating the device design and include risk analysis in its validation of the device. “Specifically, you have not conducted any risk analysis for the SIGN Fin Nail design and you could not justify why it would not be appropriate to do so,” the letter said. “You should have conducted a risk analysis when you significantly changed the design of the device and added new indications for use.”

The firm did not have written MDR procedures at the time of the incidents,  but the procedures the firm provided the FDA at the end of its inspection appear adequate, the letter said.
 
SIGN spokesman Doug Donnelly said the company took immediate action to correct all the violations. “It is our full intention that no violations like that occur again,” he added.