FDA WARNING_LETTER - Extremity Medical, LLC - October 24, 2011

This FDA Warning Letter to Extremity Medical, LLC, dated December 12, 2011, details violations observed during an inspection from September 28 to October 24, 2011. The firm manufactures orthopedic devices for distal extremities.

The devices are misbranded under Section 502(t)(2) of the Act due to failures in Medical Device Reporting (MDR) per 21 CFR Part 803. Specifically, the firm failed to submit reports for a serious injury (PER #11-007, patient non-union requiring osteotomy) and a device malfunction likely to cause serious injury if recurrent (PER #11-074, broken lag screw). The firm's MDR procedures (SOP-016, Rev. G) were inadequate, lacking clear definitions for reportable events, instructions for investigations, timely transmission protocols (e.g., awareness definition, mailing address), and documentation requirements.

The IO Fix IntraOsseous Fixation Lag Screws and X-Posts are also misbranded under Section 502(t)(2) for failing to report corrections and removals per 21 CFR Part 806.10(a). The firm distributed a revised "Surgical Technique and Quick Reference Technique Guide" for the IO Fix device in response to events (PER-10-040, -041, -04