Analysis of historical records: orthofix (b)(4) checked the internal records related to the controls made on the component code 184000 lot ae1800 before the market release.No anomalies have been found.The original lot, manufactured in 2018, was comprised of (b)(4).All of them have already been distributed to the market.According to orthofix (b)(4) historical records, this is the second event notified in regards to this specific device lot from the same hospital and surgeon.Technical evaluation: the involved device was received on april 14, 2020 by orthofix (b)(4) quality engineering department.The technical evaluation is in progress.Medical evaluation: the information made available on the case was sent to our medical evaluator.A preliminary medical evaluation was performed and will be finalized once the results of the investigation are available.As soon as the results of the investigation are available, orthofix (b)(4) will provide a follow up report.Orthofix (b)(4) continues monitoring the devices on the market.(b)(4).
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Analysis of historical records orthofix srl checked the internal records related to the controls made on the component code 184000 lot ae1800 before the market release.No anomalies have been found.The original lot, manufactured in 2018, was comprised of 6 devices.All of them have already been distributed to the market.According to orthofix srl historical records, this is the second event notified in regards to this specific device lot from the same hospital and surgeon.Technical evaluation the returned device, received in assembled conditions on april 14, 2020, was examined by orthofix srl quality engineering department.The returned device was disassembled and all components were subjected to visual and functional check as per orthofix specifications.The visual check did not evidence any anomalies.The components were then re-assembled and a functional check was performed: - the connection and disconnection with a control screw was performed (as reported at page 20 of the operative technique, re.Pm_pcp).No anomalies have been found.The components of the screwdriver can be disassembled only by pushing the proper buttons.The results of the technical evaluation concluded that the returned screwdriver was originally conforming to orthofix specification.The device still performs properly.The cause of the problem remains unknown.Medical evaluation the information made available on the event together with the results of the technical evaluation were sent to our medical evaluator.Please find below an extract of the medical evaluations performed.- april 13, 2020: "in this case a patient was having a pc.C.P inserted.A part of the screwdriver handle became loose during the operation, and caused a delay of 30 minutes.Except for this the operation was as planned.We have no more information at present and must wait for the components to be returned".(b)(6) 2020 with the results of the technical evaluation: "the original story that we received was that the handle came loose from the screwdriver and it no longer functioned as specified.However, when tested at orthofix it was found that the screwdriver is functioning normally, and there is no sign of this type of malfunction.This is always unsatisfactory, because we are unable to explain how this event happened.The suggestion is that there was some local effect that caused this, as the instrument is normal".Final comments the results of the technical evaluation concluded that the returned screwdriver was originally conforming to orthofix specification.The device still performs properly.The cause of the problem remains unknown.The medical evaluation evidenced as follows: "in this case a patient was having a pc.C.P inserted.A part of the screwdriver handle became loose during the operation, and caused a delay of 30 minutes.Except for this the operation was as planned.We have no more information at present and must wait for the components to be returned.The original story that we received was that the handle came loose from the screwdriver and it no longer functioned as specified.However, when tested at orthofix it was found that the screwdriver is functioning normally, and there is no sign of this type of malfunction.This is always unsatisfactory, because we are unable to explain how this event happened.The suggestion is that there was some local effect that caused this, as the instrument is normal".Orthofix srl continues monitoring the devices on the market.
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