MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE ROBOTIC DRILL; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number ROB10013

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/11/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during a cori assisted tka surgery, the handpiece (ri robotic drill) wasn't able to pass registration a few times, the error "robotic drill cable disconnected" appeared.They had to quit the case, disconnect the bur and push locking mechanism back.They connected handpiece back, resumed the case, continue registration, but had the same issues.Tried three times and the issue persisted.Also, the long attachment was stuck and not able to disconnect.They changed the handpiece, created new case, tried to register again and same issues, same error, but on the second attempt with new handpiece.The error was "communication failure" follow by internal error warning (the system has detected that the application unexpectedly exited).The procedure was completed by changing to manual procedure.After the case they checked the second robotic drill and it passed tests and registration, so it seems to be good.

Manufacturer Narrative

The real intelligence robotic drill, pn: rob10013, sn: (b)(6) used for treatment was not returned to the designated complaint unit for evaluation, therefore visual and functional evaluations could not be performed.The product was not returned however the software files were downloaded from the device and provided for investigation.The reported robotic drill cable disconnected errors and system fault communication failure error were confirmed.The screenshots of the case file provided confirm a robotic drill cable disconnected error with the second drill (sn000175).The user then switched to drill sn500186, where the robotic drill cable disconnected error occurred in the connection screen twice, and the system fault communication failure error occurred in the set up screen after these two disconnect errors.The log files necessary (naviosystem.Log) to identify the cause of the robotic drill disconnect errors and the system fault communication errors were not provided.The most likely cause of the robotic drill cable disconnect errors are occurrences of a known software bug, where fixes were implemented to reduce the probability of false robotic drill disconnect errors in the release of cori-v1.4.3 software.A possible cause of the system fault communication failure error and subsequent internal error could be a result of the drill¿s inability to move the carriage to the location that engages with the long attachment which allows for proper insertion of the bur.The long attachment will get stuck on the drill if the carriage is not in the correct position that allows the lock ring to rotate and unlock the long attachment.This could possibly be due to an obstruction within the long attachment, or an issue with the drill¿s exposure motor that can¿t move the carriage to the correct location.In the event of a system failure, cori has a built-in auto-recovery mechanism.If the failure occurs outside of the application, cori returns to the beginning of the startup sequence.Refer to the recovery procedure guidelines in the real intelligence cori for knee arthroplasty user manual.A failure can consist of, but is not limited to, a system software crash, unrecoverable hardware failure, handpiece failure with no backup available, tracker failure or loss of contact with bone that is unrecoverable, etc.This situation is captured in the risk assessment released at the time of the complaint.The failure mode and associated risk have been anticipated within the risk file.As a result of the risk assessment the documented risk level requires further investigation and possible adjustment by the site quality team.A review of manufacturing records indicate the software met all specifications upon release into distribution.A complaint history review found similar reports.Escalation actions applicable to the scope of the reported complaint have been identified, and it was determined that no further action is required at this time.This issue will be continuously monitored through complaint investigation and post market surveillance.Based on the investigation, no containment or further corrective actions are recommended at this time.

Manufacturer Narrative

The real intelligence robotic drill, pn: rob10013, sn: (b)(6) used for treatment was not returned to the designated complaint unit for evaluation, therefore visual and functional evaluations could not be performed.The product was not returned however the software files were downloaded from the device and provided for investigation.The reported robotic drill cable disconnected errors and system fault communication failure error were confirmed.The screenshots of the case file provided confirm a robotic drill cable disconnected error with the second drill (b)(6).The user then switched to drill (b)(6), where the robotic drill cable disconnected error occurred in the connection screen twice, and the system fault communication failure error occurred in the set up screen after these two disconnect errors.The log files necessary (naviosystem.Log) to identify the cause of the robotic drill disconnect errors and the system fault communication errors were not provided.The most likely cause of the robotic drill cable disconnect errors are occurrences of a known software bug, where fixes were implemented to reduce the probability of false robotic drill disconnect errors in the release of cori-v1.4.3 software.A possible cause of the system fault communication failure error and subsequent internal error could be a result of the drill¿s inability to move the carriage to the location that engages with the long attachment which allows for proper insertion of the bur.The long attachment will get stuck on the drill if the carriage is not in the correct position that allows the lock ring to rotate and unlock the long attachment.This could possibly be due to an obstruction within the long attachment, or an issue with the drill¿s exposure motor that can't move the carriage to the correct location.In the event of a system failure, cori has a built-in auto-recovery mechanism.If the failure occurs outside of the application, cori returns to the beginning of the startup sequence.Refer to the recovery procedure guidelines in the real intelligence cori for knee arthroplasty user manual.A failure can consist of, but is not limited to, a system software crash, unrecoverable hardware failure, handpiece failure with no backup available, tracker failure or loss of contact with bone that is unrecoverable, etc.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.A review of manufacturing records indicate the software met all specifications upon release into distribution.A complaint history review found similar reports.Escalation actions applicable to the scope of the reported complaint have been identified, and it was determined that no further action is required at this time.This issue will be continuously monitored through complaint investigation and post market surveillance.Based on the investigation, no containment or further corrective actions are recommended at this time.

Manufacturer Narrative

H3, h6: the real intelligence robotic drill, part number rob10013, serial number (b)(6), intended for treatment was returned for evaluation.The reported problem could not be confirmed with a visual inspection.The reported problem was confirmed with a functional evaluation.A torque screwdriver set at 20 lbs was used to check whether the torque of the retaining screw - it was out of specifications.The retaining nut did not have loctite on it.The retaining nut was loose.The retaining nut was loosened completely to detach the drill attachment and tracker from the drill.A known good drill attachment was connected to the drill and the kpc was completed successfully.The drill attachment was confirmed faulty.No problem found with the drill.The software files were downloaded from the device and provided for investigation.The reported robotic drill cable disconnected errors and system fault communication failure error were confirmed.The screenshots of the case file provided confirm a robotic drill cable disconnected error with the second drill (b)(6).The user then switched to the second drill (b)(6), where the robotic drill cable disconnected error occurred in the connection screen twice, and the system fault communication failure error occurred in the set up screen after these two disconnect errors.The log files necessary (naviosystem.Log) to identify the cause of the robotic drill disconnect errors and the system fault communication errors were not provided.A possible cause of the system fault communication failure error and subsequent internal error could be a result of the drill¿s inability to move the carriage to the location that engages with the long attachment which allows for proper insertion of the bur.The long attachment will get stuck on the drill if the carriage is not in the correct position that allows the lock ring to rotate and unlock the long attachment.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.In the event of a system failure, cori has a built-in auto-recovery mechanism.If the failure occurs outside of the application, cori returns to the beginning of the startup sequence.Refer to the recovery procedure guidelines in the real intelligence cori for knee arthroplasty user manual.A failure can consist of, but is not limited to, a system software crash, unrecoverable hardware failure, handpiece failure with no backup available, tracker failure or loss of contact with bone that is unrecoverable, etc.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.A historical review concluded that the lot, serial number or part number reported in this event is related to a corrective/preventive action.We have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The most likely cause of this event is associated with the loose retaining nut of the drill attachment.As a part of corrective action a design change was implemented.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.

Manufacturer Narrative

H7: if remedial action initiated, check type and h9: if action reported to fda under 21 usc 360i(f), list correction/removal reporting number section h3, h6: 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.In the event of a system failure, cori has a built-in auto-recovery mechanism.If the failure occurs outside of the application, cori returns to the beginning of the startup sequence.Refer to the recovery procedure guidelines in the real intelligence cori for knee arthroplasty user manual.A failure can consist of, but is not limited to, a system software crash, unrecoverable hardware failure, handpiece failure with no backup available, tracker failure or loss of contact with bone that is unrecoverable, etc.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.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.We have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The most likely cause of this event is associated with the loose retaining nut of the drill attachment.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.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.H6: component code, type of investigation, investigation findings and investigation conclusions.

• Brand Name: REAL INTELLIGENCE ROBOTIC DRILL
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14907028
• MDR Text Key: 295246617
• Report Number: 3010266064-2022-00513
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757321
• UDI-Public: 00885556757321
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K201022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROB10013
• Device Catalogue Number: ROB10013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: RES# 93620
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention