Model Number ROB10013 |
Device Problems
Intermittent Continuity (1121); Connection Problem (2900); Mechanics Altered (2984)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/28/2021 |
Event Type
malfunction
|
Event Description
|
It was reported that, during machine setup for a cori assisted surgery, the error robotic drill critical error ("the robotic drill has an internal error.Check the robotic drill and press continue to try again.") was displayed.It was also not detected for kpc testing.The case was completed with navio technology without significant delays.The patient was not harmed beyond the reported problem.According to the investigation, it was found that in the robotic drills, the exposure motor encoder is failing to communicate with the system console.
|
|
Manufacturer Narrative
|
Internal complaint reference: (b)(4).The sample is under evaluation by manufacturing site.
|
|
Manufacturer Narrative
|
H3, h6: the real intelligence robotic drill, p/n rob10013, (b)(6), intended for used 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 functionality confirmed.A kpc test was try to be run unsuccessfully.Drill critical error occurred during testing.A case was tried as well, and a timeout error message occurred followed by a drill flicker icon at the connection screen.The most likely cause of this event was that the drill exposure motor encoder is failing to communicate with the system console.Refer to cori user manual appendix d: recovery procedure guidelines for guidelines for recovering to a fully manual procedure.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 has identified prior 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.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.
|
|
Manufacturer Narrative
|
H3, h6: the real intelligence robotic drill, p/n rob10013, (b)(6), intended for used 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 functionality confirmed.A kpc test was try to be run unsuccessfully.Drill critical error occurred during testing.A case was tried as well, and a timeout error message occurred followed by a drill flicker icon at the connection screen.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.Refer to cori user manual appendix d: recovery procedure guidelines for guidelines for recovering to a fully manual procedure.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 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.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.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.H11 ¿ corrected data g2- report source.
|
|
Search Alerts/Recalls
|
|