A nurse manager reported that on (b)(6) 2019, the a1059 mayfield modified skull clamp failed during a posterior cervical case.The torque knob pressure released when the patient was pinned and placed in position for surgery.This caused the patient's head to shift which resulted to a 5-inch scalp laceration, which was stapled to close.Additional information received on 17oct2019 and 30oct2019 indicating that the patient was initially positioned from supine to prone position.The lacerated scalp was cleansed with betadine and repaired with 5 staples.It was reported that the (b)(6) male patient is currently in critical care unit with unstable condition but not as a result from the scalp laceration.There was about 20 to 40 minutes delay in surgery with no adverse consequence to the patient.The procedure was completed with a borrowed clamp from another facility.
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Additional information - device identifier #: (b)(4).The device was returned to the manufacturer for evaluation.Device history record reviewed with no abnormalities related to the reported failure.The device passed all required inspection points with no associated mrr¿s, variances or rework.Sampling plan reviewed and is acceptable.Device is 100% tested prior to final acceptance.The reported complaint of " torque knob pressure released " was not confirmed from the evaluation of the device the device was functioning as designed with no difficulty.The definite root cause of the reported cannot be reliably determined.No issue was found with the device.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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