FDA WARNING_LETTER - Trilliant Surgical, LTD - January 20, 2010

On November 30, 2009, through January 20, 2010, the FDA inspected Trilliant Surgical, LTD, a manufacturer and distributor of the Tiger Cannulated Screw Fixation System and the 3S Hemi Toe Implant. The inspection revealed these devices are adulterated under section 501(h) of the Act, as their manufacturing, packing, storage, or installation methods and controls do not conform to the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Significant violations include: 1. Failure to adequately investigate nonconformities, specifically regarding three complaints of driver bits breaking during surgery (CAR #001, ECN #1010). The investigation lacked sufficient detail on user mishandling and failed to explain why mechanical tests didn't detect impact fractures. (21 CFR § 820.100(a)(2)) 2. Failure to verify or validate corrective and preventive actions and document results. Addendum #2 to CAR #001 lacked test data, statistical sample size, simulated use conditions, and proper signing/dating for the redesigned driver bit. (21 CFR § 820.100(a)(4), 820.100(b)) 3. Failure to establish and maintain adequate procedures for design validation,