Specification Developer Fumbles on Medical Device Report Submissions

The FDA has cited specification developer Blue Belt Technologies following an inspection of its Pittsburgh, Pa., facility for not submitting timely medical device reports (MDRs) to the agency.

The FDA investigator found that the company received at least 14 complaints between 2014 and 2019 which were associated with malfunctioning Navio tissue protectors and bone pins during surgery, but MDRs for 10 complaints were not submitted to the FDA within the specified timeframe, and reports for four complaints were not submitted at all.

The investigator also found that the firm’s corrective and preventive action (CAPA) procedures were inadequate. For example, it did not implement a CAPA in response to reports that the tissue protector became stuck on bone screws.