FDA EIR - Arthrex, Inc. - October 30, 2009

An FDA inspection of Arthrex, Inc., a manufacturer of Class I and Class II orthopedic and arthroscopic surgical devices in Naples, FL, was conducted from October 27-30, 2009. This "for cause" inspection, requested by CDRH, focused on compliance with Quality System Regulation (QSR) and Medical Device Reporting (MDR) regulations, particularly regarding arthroscopic shaver handpiece cleaning validation and safety alert activities.

The inspection followed up on deficiencies noted in a previous 2008 inspection, which included inadequate corrective and preventive actions and incomplete design control procedures. While Arthrex had addressed some prior observations, new deviations were identified. Key issues included the firm’s failure to adequately verify or validate specification changes and ensure validated cleaning procedures were incorporated into final device labeling. Discrepancies were noted in cleaning instructions for different documents (pH balanced vs. enzymatic detergent). Furthermore, the company lacked proper training for device cleaning for employees and end-users and used an inappropriate manual device as a "worst-case" for cleaning validation of powered shaver handpieces. The firm also failed to initiate a formal Corrective and Preventive Action (CAPA) in response to an FDA safety alert.

An FDA-483 was issued to management, who committed to corrections and provided a written response. The immediate observations on the 483 were reportedly corrected and verified before the inspection concluded, with appropriate warnings given.