Hand Biomechanics Lab, a manufacturer of bone fixation fastener systems in Sacramento, California, was hit with an FDA warning letter for failing to submit MDRs and for GMP nonconformities.
The firm’s procedure for MDR submissions lacked definitions for terms such as “become aware,” “caused or contributed,” and “MDR reportable event” that may have caused it to make inappropriate decisions when evaluating complaints. It was also flagged for incomplete investigations and for not providing timely MDR submissions.
The firm failed to submit MDRs after it received at least three complaints regarding patients who required prescription antibiotics for pin site infections developed while being treated with the Digit Widget device, and another complaint about a patient having the device surgically removed due to the infection sustained with use.
The firm did not submit MDRs to the agency for these complaints and others, according to the warning letter, even though they describe events in which “medical intervention was necessitated to preclude permanent impairment of a body function or permanent damage to a body structure.”
The GMP nonconformities that resulted in adulterated devices relate to failing to demonstrate the sealing process could produce “repeatable and reproducible seals capable of maintaining seal integrity throughout the shelf-life of the product” and evaluating defects.
In addition, at least 10 CAPA records between Feb. 24, 2015 and Feb. 3, 2017 lacked investigations, corrective actions or preventive actions, the FDA said.