During a craniotomy, the perforator stopped rotating while performing the 3rd burr hole, although the 1st and 2nd burr holes were made without problem.The 3rd burr hole was done by cutter bar.The same event occurred during the 4th burr hole.There was surgical delay within 30 minutes with no adverse consequence to the patient.The physician commented that the patient's cancellous bone was softer.The perforator was used for the first time.
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The perforator was received for evaluation.Dhr - dhr could not be performed as a lot number for the complaint product was not provided.Udi (b)(4).Failure analysis: visual inspection showed no anomalies except a torn label and slight staining.Results of instructions for use - unit was found to performed as intended.Results of functional test - was found to performed as intended the root cause is undetermined and was unable to be confirmed in the complaint investigation.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.
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