Additional information - d10, g4, g7, h2, h3, h6, h10 udi # (b)(4) the device was returned for evaluation.Investigation showed that the unit's lock had rotational and lateral movement, residue build up was present, worn out internal components, and failed several of the specific functional tests.The reported complaint was confirmed.The dhr review was not possible as no other lot or serial number was provided during the course of the complaint investigation.Additional information received on 11may2020 stating that the complaint was raised on 11mar2020.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) office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.
|