A distributor reported that the a2114 mayfield infinity xr2 skull clamp had a backlash.According to the customer, although the rocker arm was connected and locked on the two pin side using the knob, the rocker arm was not fixed completely and still there was a backlash.The device was not in contact with the patient nor there was patient injury/death alleged.There was no surgical delay.
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Additional information - d10, g4, g7, h2, h3, h4, h6, h10.Device identifier (b)(4).The device was returned for evaluation.The device history record was reviewed with no abnormalities related to the reported failure.The device passed all required dimension check and inspection points with no associated mrr¿s, variances or rework.The evaluation and functional testing of the returned unit showed that the rocker arm had slight movement when attached and put in the lock position.This might affect the intend use of the device and the reported complaint was confirmed.The skull clamp pass all functional test at the time of manufacture.The observed condition is likely caused by damage to the lock mechanism/ improperly handling of the skull clamp.The definite root cause of the observed condition cannot be reliably determined.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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