Updated fields: d4, d10, g4, g7, h2, h3, h4, h6, h10 device identifier # (b)(4) the received lot number is j4867z however, the reported lot number was j59k60 device history record (dhr) - there is no indication that the production process may have contributed to this complaint failure analysis - complaint could not be verified.The perforator was found to meet all applicable acceptance criteria.The complaint was reported as lot j59k60 but, a unit from lot j4867p was turned in for testing.This is most likely due to a mix up when the customer made the report.- visual inspection: the unit was observed to have organic matter rust and a worn label instruction for use, functional test per procedure was found to perform as intended the root cause cannot be confirmed, as no issues relevant to the failure were noted from the device history record (dhr) review, trending, or failure analysis and proper finished goods testing was performed prior to release.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.
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