Catalog Number PFSDV0016 |
Device Problems
Nonstandard Device (1420); Optical Problem (3001)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/07/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference number: (b)(4).
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Event Description
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It was reported that, during a cori assisted tka procedure, the navio flat markers were not being seen by the camera.They flickered and won't fully be seen.Even after replacing some of them, they were still not able to be fully seen.The procedure was resumed, after a significant delay, with a s+n back-up device.Patient was not injured as consequence of this problem.
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Manufacturer Narrative
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The navio flat markers, part number pfsdv0016, lot number 23gk00137, 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.Should any additional information be received, the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.
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Manufacturer Narrative
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H3, h6: the navio flat markers, part number pfsdv0016, lot number 23gk00137, 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.Should any additional information be received the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.Additional information: h7 corrected data: h6 (medical device problem code).
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Search Alerts/Recalls
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