Ascension Orthopedics, Inc – FDA Warning Letter, Mar 8, 2010

The FDA issued a Warning Letter to Ascension Orthopedics, Incorporated following an inspection from March 3-8, 2010, concerning their Interphalangeal (PIP) Trial devices. The inspection revealed that the devices were misbranded due to the firm's failure to furnish required information under sections 502(t)(2) and 519 of the Act, specifically regarding Reports of Corrections and Removals (21 CFR Part 806) and Medical Device Reporting (MDR) (21 CFR Part 803).

Key violations included the failure to submit a written report to FDA within 10 working days for a Class II recall of oversized trials (21 CFR 806.10(a)(1)). The firm also failed to submit MDRs within 30 days for serious injuries (e.g., bone fracture requiring suture) (21 CFR 803.50(a)(1)) and for device malfunctions that would likely cause serious injury if they recurred (21 CFR 803.50(a)(2)). Furthermore, Ascension Orthopedics failed to develop, implement, and maintain adequate written MDR procedures (21 CFR 803.17). An additional nonconformity with Quality System (QS) regulation (21 CFR Part 820) was the failure to properly review, evaluate, and investigate complaints, as evidenced by incorrect conclusions regarding patient harm in a complaint involving a bone fracture (21 CFR 820.198(c)).

The FDA deemed the firm's responses incomplete or inadequate, noting a lack of documented corrective actions and updated procedures. Ascension Orthopedics must take prompt action to correct these violations within fifteen working days, providing documentation and a timetable for implementation. Failure to comply may result in regulatory actions such as seizure, injunction, civil money penalties, and impact on federal contracts.