Procedural Problems at Smith & Nephew Facility Prompt FDA Warning Letter

A warning letter from the U.S. Food and Drug Administration (FDA) over quality control violations Smith & Nephew plc’s Andover, Mass., facility has prompted the company to suspend shipments of its Truclear Ultra Reciprocating Morcellator 4.0 as it investigates customer complaints.

The April 30 letter claims Smith & Nephew failed to establish and maintain procedures for verifying and validating corrective and preventive actions after receiving customer complaints about the loss of visualization with its Truclear Morcellator, a disposable blade that attaches to the Truclear Hysteroscope 8.0 for removing intrauterine tissue.

“For example, during the inspection eight corrective action reports were reviewed and did not contain sufficient information to ensure corrective actions were completed and verified as effective,” the letter stated.

The FDA contends the company’s corrective action report about the problem contained insufficient information to prove that the issue had been resolved, said Smith & Nephew continues to receive complaints about the problem — more than two and a half years after the issue was first raised (September 2012). The letter also accuses Smith & Nephew of removing a prior hold on the morcellator in 2012 before completing its review of the complaints, in violation of the company’s own policy.

Other findings mentioned in the letter include the incorrect translation of instructions for use of the TwinFix Ultra Preloaded Suture Anchors (used to secure sutures, or stitches, in place), failure to document required tasks following complaints of breakage of the Beaver Blade device (a disposable blade used during hip surgery), and failure to test the effect of some sterilization cycles on the Truclear Ultra Reciprocating Morcellators. The FDA also claims that some internal audits were not conducted at the facility, violating the company’s own procedure.

The FDA conducted an inspection of the Andover facility March 4 to 26. It said Smith and Nephew has hired additional employees to help with audit functions and conduct reaudits.

“These corrective actions appear adequate to address the violation. In response to this Warning Letter, please inform us of when these actions have been completed,” the letter states.

Smith & Nephew has not publicly addressed the warning letter.