The device was returned for evaluation.Dhr - a review of the lot records was conducted and there were no indications of problems that could have caused or contributed to the complaint.Failure analysis determined that the lateral peg of the implant was more strongly fixated than the rest of the implant.This difference in fixation caused the lateral peg to be loaded in bending, resulting in the fracture.Root cause - the insufficient fixation of the implant lead to fatigue failure of the lateral peg.There was one 10207111 cadence tibial tray, size 1x, right returned with the complaint that the lateral peg of the tibial component broke, caused loosening and shift of the implant.The failure was confirmed.A review of the lot records was conducted and there were no indications of problems that could have caused or contributed to the complaint.The product development engineer concluded that the implant had insufficient fixation, leading to fatigue failure of the lateral peg.Between (b)(6) 2019 and (b)(6) 2020, approximately 2,200 mdrs submitted electronically by integra lifesciences via trackwise, integra's complaint handling system, were not received by cdrh due to a computer system issue.Within this time period, an error with integra's middleware, which facilitates communications between trackwise and the fda system, caused the complaint records to close and indicate we had received an acknowledgement 3 from the fda when we had not.Integra interpreted the acknowledgement as a successful submission; however, subsequent investigation revealed the acknowledgement 3 received was from our middleware and not from the fda (these acknowledgements have been retained as part of the documentation of the mdr).The malfunction was related to the relocation of the trackwise application to a new data center during the transition of integra's corporate headquarters from plainsboro, nj to princeton, nj.Previously, integra had been successfully receiving acknowledgements 1, 2, and 3 from the fda, and our records reflect these acknowledgements, including the date and time stamps.Capa pr 229048 and nc 20-011 have been opened by integra to further investigate the nonconformance and develop a corrective action plan.The middleware error has been corrected, and integra has filed mdrs since the correction and verified that the appropriate acknowledgements have been received from the fda.Integra is resubmitting all impacted mdr reports for the time period (b)(6) 2019 through (b)(6) 2020.Integra lifesciences contacted (b)(6) , director of regulatory programs, office of product evaluation and quality and (b)(6) , assistant director, mdr team, office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.
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