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 Type
Injury
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Manufacturer Narrative
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Internal complaint reference (b)(4).
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Event Description
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It was reported that, during a cori assisted tka surgery, they could not recover from drill disconnect errors and the surgery had to be completed with manual instrumentation.No significant delays were reported.The patient was not harmed.
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Manufacturer Narrative
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H3, h6: the real intelligence robotic drill, part number rob10013, used for treatment was not returned for evaluation; thus, a visual and functional evaluation could not be performed and a relationship between the reported event and the device could not be established.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 internal exposure motor connectivity issue.While all products meet required manufacturing specifications prior to release, a serial number, lot number, part revision or software version is required to link the device to a dhr or nc investigation.A complaint history review for similar reported/confirmed complaints has identified prior events.A historical escalation event review was not completed.The product was not returned and no evidence was made available to link the complaint to an escalation event.Refer to the real intelligence cori for knee arthroplasty user manual, section setting up a cori knee procedure: setting up the instruments, connecting the robotic drill for proper set up and handling.As a result of the risk assessment the documented risk file will undergo further investigation and possible adjustment by the site quality team.Per complaint details from the us, it was reported that, during a cori assisted tka surgery, they could not recover from drill disconnect errors and the surgery had to be completed with manual instrumentation.No significant delays were reported.The patient was not harmed.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.
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Manufacturer Narrative
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The real intelligence robotic drill, part number rob10013, used for treatment was not returned for evaluation; thus, a visual and functional evaluation could not be performed and a relationship between the reported event and the device could not be established.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.While all products meet required manufacturing specifications prior to release, a serial number, lot number, part revision or software version is required to link the device to a dhr or nc investigation.A complaint history review for similar reported/confirmed complaints has identified prior events.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.Refer to the real intelligence cori for knee arthroplasty user manual, section setting up a cori knee procedure: setting up the instruments, connecting the robotic drill for proper set up and handling.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.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, and 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.
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Search Alerts/Recalls
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