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 07/19/2022 |
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 set up for a cori assisted surgery, the real intelligence robotic drill was not getting detected.The drill is showing deactivated.The procedure was completed, with a significant delay, using manual procedure.Patient was not harmed beyond the problem reported.
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Manufacturer Narrative
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The real intelligence robotic drill, part number rob10013, serial number (b)(6), intended for treatment was not returned for evaluation, therefore a device analysis was unable to be performed.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.Refer to the real intelligence cori for knee arthroplasty user manual (500230 rev d) page 27, section ¿assembling the robotic drill¿, and page 30, section ¿connecting the robotic drill¿ for proper connection, 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 within the product risk profile.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.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with a loose internal connector.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.E1: name and address.
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Manufacturer Narrative
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H6: health effect - impact code.
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Manufacturer Narrative
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H3, h6: the cori, real intelligence robotic drill, part number rob10013, sn(b)(6), intended for use in treatment was returned for evaluation.The exterior condition shows minor wear (scratches/scuffs).Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.The exposure control motor is faulty.All encoder pins are dead.The most likely cause for the drill not getting detected is the faulty exposure control motor.The exposure motor failed 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.Refer to the real intelligence cori for knee arthroplasty user manual (500230 rev d) page 27, section ¿assembling the robotic drill¿, and page 30, section ¿connecting the robotic drill¿ for proper connection, 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.Further investigation into the reported failure is being conducted to determine if additional actions are required.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 cori, real intelligence robotic drill, part number rob10013, (b)(6), intended for use in treatment was returned for evaluation.The exterior condition shows minor wear (scratches/scuffs).Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.The exposure control motor is faulty.All encoder pins are dead.The most likely cause of this event is associated with 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.The exposure motor failed 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.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 (500230 rev d) page 27, section ¿assembling the robotic drill¿, and page 30, section ¿connecting the robotic drill¿ for proper connection, 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.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.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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