A senior neurospecialist reported that on (b)(6) 2019, the 261221 codman dispos perforator, was deemed unacceptable prior to use on patient.Additional information was received on 07/09/2019 indicates that the other 2 perforators were opened and ¿tested¿ to see the clutch was functioning and both were noted not to depress and ¿lock¿ as they are expected to so they were not used on patients.There was no patient contact, thus no patient injury.There was no surgery delay.
|
Dhr - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - complaint could not be verified.Unit was found to meet all applicable acceptance criteria.The initial reported complaint was unconfirmed.Tested within specifications.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.Between 05nov2019 and 30jun2020, 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 05nov2019 through 30jun2020.Integra lifesciences contacted (b)(4), director of regulatory programs, office of product evaluation and quality and (b)(4), assistant director, mdr team, office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.
|