TriMed, a maker of implantable bone fixation systems, failed to report a device failure that required surgery to remove the device, according to an FDA warning letter.
In February 2014, the company learned about the breakage of an implanted fixation plate, which was associated with the need for surgery, according to the June 30 letter. But the Santa Clarita, Calif., company had not submitted an MDR for the event at the time of the FDA’s March 2016 inspection.
Posted on the FDA’s website Aug. 2, the warning letter cites two other complaints that linked the company’s osteotomy device and pin plate with a malfunction.
It notes that a malfunction of long-term implantable devices is reportable. However, TriMed did not submit MDR reports within 30 days of receiving or becoming aware of the events.
Additionally, the FDA saw “no evidence to justify whether the malfunctions would not be likely to cause or contribute to a death or serious injury, if they were to recur.”
The company’s MDR procedure did not set up systems for timely and effective identification, communication and evaluation of events that might fall under MDR requirements.
Further, TriMed’s nonconforming product procedure did not require non-conformances to be evaluated to see if an investigation was needed, and it did not require the company to document any investigations that were conducted.
CAPA procedures also drew the FDA’s attention during the inspection.
In September 2015, TriMed initiated a CAPA referencing non-locking semi-tubular screw plate screws that were passing through the hole of the semi-tubular bone plates, allowing the screws to pass through the plates. It received plates from the field during that month but did not submit a written report of the removal to the FDA, the letter says.
TriMed’s CAPA procedures did not include a requirement to analyze sources of quality data, including complaints documented in the error log, non-conformances documented in the material review board log and returned products documented in the returned goods authorization log.
In addition, one CAPA was initiated in September 2015 to address complaints of non-locking screws that were passing through the hole of the plate.
The CAPA appeared to have been implemented in early October 2015 and deemed effective in February 2016; however, there was no documentation to show the corrective action — revising the dimension of the screw hole — was effective.
The corrective action plan notes that other bone plates using the same threaded screw hole could have the same issue, but the CAPA does not list the affected products or provide documentation that effective corrective actions were taken for all products affected. Meanwhile, TriMed did not document the failure mode of non-locking screws passing through the hole of bone plates during surgeries in its risk analysis for the Supracondylar Elbow Implant System.
The warning letter also notes that some finished products shipped to a customer did not include records showing completion of certain activities required in the device master record for the Wrist Fixation System, Radiocarpal Fusion System and Ulnar Osteotomy System.
TriMed told IDDM that the company has taken all the necessary actions and submitted the required documentation within the FDA’s deadline.