Model Number ROB10013 |
Device Problem
Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/22/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that, during a cori assisted tka procedure, when they tried to load the burr there was an error message that said: "re-establish connection", they tried to unplug the handpiece and then switch off the device but it didn't work.They cannot move forward that message scree.The cori case was aborted and the procedure was completed with manual instrumentations and no patient injuries were reported.It is unknown if there was a delay in the procedure.
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Manufacturer Narrative
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H3, h6: the real intelligence robotic drill, part number rob10013, serial number (b)(6), used for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.The clinical/medical investigation concluded that based on the information provided, there was no surgical delay or patient injury/harm and the procedure was completed successfully.Patient impact beyond the reported modified procedure using manual instrumentation to complete the tka would not be anticipated.No further medical assessment is warranted at this time.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.Refer to the real intelligence cori for knee arthroplasty user manual (500230 rev d) page 27, section ¿assembling the robotic drill¿ for proper set up and handling of the real intelligence robotic drill.The failure mode and associated risk have been anticipated within the risk file.As a result of the risk assessment the quality team has been notified for further investigation.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with an exposure motor encoder failure.Based on the investigation, the need for a corrective action is not recommended or required at this time.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 real intelligence robotic drill, part number rob10013, serial number (b)(6), used for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.The clinical/medical investigation concluded that based on the information provided, there was no surgical delay or patient injury/harm, and the procedure was completed successfully.Patient impact beyond the reported modified procedure using manual instrumentation to complete the tka would not be anticipated.No further medical assessment is warranted at this time.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.Refer to the real intelligence cori for knee arthroplasty user manual (500230 rev d) page 27, section ¿assembling the robotic drill¿ for proper set up and handling of the real intelligence robotic drill.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.We have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A historical review concluded that the lot, serial number or part number reported in this event is related to a corrective/preventive action already implemented.Although the reported problem was not confirmed through a visual or functional evaluation, factors that may have contributed to the reported symptom may be associated with an intermittent failure of the drill exposure motor due to the thermo-mechanical stress induced within the motor at the encoder and electrical noise on the console error status inputs to the drill exposure motor encoder.Continuous improvements have been made to the cori robotic drill and manufacturing processes to reduce drill disconnection error messages.These improvements consisted of: 1.A hardware update to the cori console to reduce noise on the internal electronics.2.An update to the cori system¿s software and firmware to improve the user experience when error messages are displayed.3.A hardware update to the cori drill to reduce mechanical stress on drill exposure the motor.The first two improvements are fully deployed.The third improvement is being deployed for new orders and as drills are returned for routine servicing.Also, smith+nephew is voluntarily performing a recall/field notification for the cori real intelligence robotic drill.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.H10- additional information d10- concomitant medical products h11- corrected data b5- describe event or problem ¿ typo amended.G2- report source.
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Event Description
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It was reported that, during a cori assisted tka procedure, when they tried to load the burr there was an error message that said: "re-establish connection", they tried to unplug the handpiece and then switch off the device but it didn't work.They cannot move forward that message screen.The cori case was aborted and the procedure was completed with manual instrumentation and no patient injuries were reported.It is unknown if there was a delay in the procedure.
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Search Alerts/Recalls
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