It was reported that during a cori assisted tka surgery, the navio flat markers were flickering and they were unable to be seen at times.The procedure was performed, after a significant delay, with the same device.Patient was not harmed as consequence of this problem.
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H3, h6: the navio flat markers, part number pfsdv0016, lot number 22mk00040, intended for treatment was returned for evaluation.The reported problem could not be confirmed with a visual inspection.The reported problem was confirmed with a functional evaluation.The flat markers will flicker when placed approximately 1.5 meters from the camera and held approximately perpendicular to the camera.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing records indicate the device met all specifications upon release into distribution.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.A historical review concluded that the lot, serial number or part number reported in this event is related to a corrective/preventive action.We have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The most likely cause of this event is associated with software settings.As part of corrective action, a software change will update the image settings to optimize flat marker detection.Smith & nephew has initiated a field action to voluntarily correct the cori surgical system.The failure mode will continue to be monitored through complaint investigation and trended through post market surveillance activities.Should any additional information be received the complaint will be reopened.
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