Model Number ROB10013 |
Device Problems
Material Deformation (2976); Unintended Application Program Shut Down (4032)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/29/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference: case-(b)(4).
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Event Description
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It was reported that, prior to a cori assisted procedure, when pressing unlock the real intelligence robotic drill gave an internal error and did not allow to insert the burr.They tried another long attachment with the same result.The procedure was performed, without any delay, with another tray.Patient was not harmed as consequence of this problem.
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Manufacturer Narrative
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The real intelligence robotic drill, part # rob10013, serial #: (b)(6), intended for use in treatment, was returned for evaluation.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.Testing found that the bur could not be inserted into the collet.Inspection with a microscope found that the internal retainers of the collet had been damaged and deformed.The most likely cause of the damaged collet seems to have been use of excessive force or improper technique during bur insertion.This could have caused a deformation to the collet socket which made it impossible to insert a bur.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints found similar events.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of the reported complaint.The failure mode and associated risk have been anticipated within the risk file including a documented risk level.Although no further containment or corrective action is recommended or required at this time, 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 # (b)(4), serial # (b)(6), intended for use in treatment, was returned for evaluation.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.Testing found that the bur could not be inserted into the collet.Inspection with a microscope found that the internal retainers of the collet had been damaged and deformed.The most likely cause of the damaged collet seems to have been use of excessive force or improper technique during bur insertion.This could have caused a deformation to the collet socket which made it impossible to insert a bur.Another factor 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.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints found similar 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 the failure mode and associated risk have been anticipated within the risk file including a documented risk level.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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