Hand Biomechanics Failed to Report Serious Injuries, FDA Says
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.