FDA Flags Faulty Design Change Procedures, Risk Analysis at TriMed
The FDA cited TriMed for numerous deficiencies such as faulty design control, inadequate design change procedures and incomplete risk analysis.
The agency’s November 2017 inspection of the firm’s Santa Clarita, California facility revealed issues with a design control procedure after the inspector reviewed the design history files for the firm’s Distal Humerus Fixation system (DHFS) and the Nitinol Sterile Staple system (NSSS).
For example, design inputs for the DHFS did not address performance requirements, such as expected product reliability under its stated uses. The sole design verification report only addressed the mechanical strength of the plates, with no records showing that other device aspects were verified.
The firm also had deficient procedures for design changes. A complaint received for a Dorsal Wrist Hook Plate alleged that “a screw went through the dorsal hook plate” and the plate seemed to be manufactured incorrectly. After investigating the complaint, it was determined that the failure was related to an unverified and unapproved design change made to the product that was not validated.
In addition, design changes made to the firm’s Humeral Supracondylar Medial Nail plate were not verified or validated, although the engineering change release lists the parts as “Use”.
In addition, the firm conducted inadequate risk analysis. It initiated corrective and preventative actions to address customer complaints about hex drivers with epoxy melting and coming off after undergoing sterilization at the user’s facilities.
Because the malfunctions risked dropping particles into surgical sites, they were deemed reportable to the FDA as medical device reports. However, the firm’s analysis for the fixation systems failed to document and assess the risks.
The firm also lacked written CAPA or complaint procedures.