Catalog Number 261221 |
Device Problem
Failure to Auto Stop (2938)
|
Patient Problem
Injury (2348)
|
Event Date 06/18/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
|
|
Event Description
|
It was reported that the perforator ended up in patients skull and had to be removed surgically.
|
|
Manufacturer Narrative
|
Dhr: the batch record was reviewed for any anomalies or ncs related to the finished lot (j35g91), and there were no findings.Failure analysis: product was not received at the testing facility.Failure analysis cannot be performed without a returned sample.Root cause: 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.
|
|
Event Description
|
N/a.
|
|
Manufacturer Narrative
|
Failure analysis - complaint could not be verified.Unit was found to meet all applicable acceptance criteria.The cause cannot be confirmed, as no issues relevant to the failure were noted from the dhr review, trending, or failure analysis, and proper finished goods testing was performed prior to release as indicated in the dhr.The risk remains acceptable per the risk analysis.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.
|
|
Search Alerts/Recalls
|
|