FDA WARNING_LETTER - Synthes USA HQ, Inc. - September 15, 2011

The FDA issued a Warning Letter to Synthes USA HQ, Inc. following an inspection from June to September 2011, which found their medical devices, including Click'X 3-D Polyaxial Heads, Click'X 3-D Pedicle Screws, and N-Hance Rods, to be adulterated. The firm's manufacturing processes and controls did not conform to the Quality System (QS) regulation (21 CFR Part 820). Significant QS violations included failures to establish and maintain adequate procedures for corrective and preventive actions (CAPA), acceptance of incoming product, and receiving, reviewing, and evaluating complaints. The firm also failed to maintain complete complaint investigation records and promptly review/investigate MDR-reportable complaints. Additionally, devices were misbranded due to non-compliance with Medical Device Reporting (MDR) requirements (21 CFR Part 803), specifically regarding untimely reporting of malfunctions, delayed submission of supplemental information, and not submitting all reasonably known information. The firm's September 29, 2011, response was largely deemed inadequate, lacking evidence of implemented corrections. Synthes must take prompt action to correct these violations, provide documentation, and submit an initial certification by an outside expert consultant by August 10, 2012, with subsequent certifications every six months. Failure to comply could lead to regulatory actions such as seizure, injunction, civil money penalties, and impact on federal contracts and device approvals. A written response detailing corrective actions is required within fifteen working days.