Ohio-based OrthoHelix Surgical Designs has received a warning letter from the FDA for failing to report a Class II recall initiated last fall.
The recall involved the company's MaxLock driver system, designed for foot and ankle internal fixation. According to the OrthoHelix website, the system contains 10 plate sizes, two screws and a variety of instruments, including a driver.
When reports emerged that the pilot tip on the MaxLock was breaking, the firm ordered a field correction and removal. OrthoHelix initiated the action last November, but the FDA first became aware of the recall after a Jan. 1031 inspection, the letter states.
"Even if you believed you were not required to report the correction or removal to FDA, you did not have a written justification for not reporting this action to FDA," the agency wrote in its recent letter to the firm. The agency noted that it considers the product to be misbranded.
Design input requirements for the MaxLock were "incomplete and ambiguous," the letter said, citing as examples that "the intended population [is] not described, [the] environment in which the product is intended to be used is not characterized, interfaces with instrumentation [are] not detailed, human factors requirements [are] not addressed, mechanical performance specifications [are] not listed for the screws and plates, and no descriptive information [is provided] regarding such specifications as: radius edges, low profile, and nonlocking screw/plate interface."
Furthermore, "the design verification results, including identification of the design, methods, the date, and the individual performing the verification, were not documented and filed in the design history file," the letter said. As an example, the agency cited a lack of document review after a contract laboratory provided mechanical testing on the MaxLock system.
The letter also pointed out that "procedures for validating the device design were not complete," noting that the device's validation plan did not define the sizes and shapes of system components being tested, or whether the implants were to be used for hand or foot surgery.
Finally, the "design verification did not confirm that the design output meets the design input requirements," the agency said.
OrthoHelix did not respond to a request for comment by FDAnews press time. To access the warning letter, visit http://www.fda.gov/foi/warning_letters/g5797d.htm (http://www.fda.gov/foi/warning_letters/g5797d.htm). ()a href="http://www.fdanews.com/ddl/33_17/" target=_blank>