Model Number ROB10013 |
Device Problems
Intermittent Continuity (1121); Connection Problem (2900); 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 09/21/2022 |
Event Type
malfunction
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Event Description
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It was reported that, during the preoperative set-up for a cori-assisted total knee arthroplasty, a real intelligence robotic drill produced a ¿communication error¿ after unlocking the drill.The procedure was finished with a smith and nephew back up device without delay.As this happened before surgery, there was no patient involvement.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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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.A relationship between the reported event and the device was established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.Test results found that the exposure motor has multiple bad pins for the encoder.The most likely cause is the exposure motor encoder inserted into motor is failing as a result of forces on the encoder board due to epoxy filler and adhesive.A possible material issue that is breaking the encoder solder joints.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.The review determined that prior escalation actions are applicable to the scope of this complaint and further investigation into the reported failure is being conducted to determine if additional escalation actions are required.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.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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The real intelligence robotic drill, part # rob10013, serial # (b)(6), intended for use in treatment, was returned for evaluation.A relationship between the reported event and the device was established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.Test results found that the exposure motor has multiple bad pins for the encoder.The most likely cause is the exposure motor encoder inserted into motor is failing as a result of forces on the encoder board due to epoxy filler and adhesive.A possible material issue that is breaking the encoder solder joints.Also, a 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 could be related with this issue.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 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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