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

Model Number ROB10024

Device Problems Intermittent Continuity (1121); Application Program Problem: Parameter Calculation Error (1449); Connection Problem (2900); Unintended Application Program Shut Down (4032)

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

Event Date 06/16/2021

Event Type  malfunction  

Event Description

It was reported that during a cori assisted surgery the real intelligence cori console had several fatal errors, internal errors, drill disconnect errors and mesh creation errors.The procedure was completed, with a delay of less than 30 minutes, by switching back to navio system.Patient was not harmed as consequence of this problem.

Manufacturer Narrative

H3, h6: the ri cori (us), rob10024, (b)(6) used for treatment was not returned for evaluation; thus, a visual and functional evaluation could not be performed, and a relationship between the reported event and the device could not be determined.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 capa, hhe/pra, field action review was not completed.The product was not returned and no evidence was made available to link the complaint to a capa, hhe/pra, field action.Although the reported problem was not confirmed, a factor that may have contributed to the reported symptom may be associated with a software issue.This failure is an identified failure mode within the risk assessment and the anticipated risk level is still adequate.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.

Manufacturer Narrative

H3, h6: the cori console, pn rob10024, (b)(4), used in treatment, was returned for evaluation.No visual or functional abnormalities were identified.The software files were downloaded from the device and provided for investigation.The following case ids were performed on the occurrence date of (b)(6) 2021.Case id (b)(4) confirmed a ¿robotic drill cable disconnected¿ error in the femur bone removal screen and incurred another ¿robotic drill cable disconnected¿ error in the femur bone removal screen after re-entering the case.The xsession.Log review found that both of these errors were triggered by the ¿bad_exposure_position_sensor¿ error.The most likely cause of the ¿robotic drill cable disconnect¿ errors triggered by the ¿bad_exposure_position_sensor¿ 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.Case id (b)(4) confirmed the ¿bone model generation error¿ in the tibia bone removal screen, twice.This error is associated with a known software issue that has also been corrected in the release of cori 1.4.3.Case id (b)(4) confirmed a ¿robotic drill cable disconnected¿ error after the connection screen at the beginning of the case, then a ¿system console is bad¿ error message in the setup screen.The user then quit this case, where an ¿internal error¿ message was identified at the end of the case.The ¿robotic drill cable disconnected¿ error looks like it was triggered by a ¿tool_homing_failure¿.This error is likely due to a drill/hardware issue.The ¿system console is bad¿ error message was confirmed and was triggered by a ¿drill current sense error,¿ which is also likely due to a drill/hardware issue.The ¿internal error¿ identified at the end of the case is a likely occurrence of a known software issue.No errors were found in case id (b)(4).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 and that 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 corrective actions are recommended at this time.

Manufacturer Narrative

The cori console, pn rob10024, (b)(6), used in treatment, was returned for evaluation.No visual or functional abnormalities were identified.The software files were downloaded from the device and provided for investigation.The following case ids were performed on the occurrence date of (b)(6) 2021.Case id (b)(4) confirmed a ¿robotic drill cable disconnected¿ error in the femur bone removal screen and incurred another ¿robotic drill cable disconnected¿ error in the femur bone removal screen after re-entering the case.The xsession.Log review found that both of these errors were triggered by the ¿bad_exposure_position_sensor¿ error.Although the reported problem was not confirmed through a visual or functional evaluation, the analysis of submitted case files confirmed the reported issues.The most likely cause of the ¿robotic drill cable disconnect¿ errors triggered by the ¿bad_exposure_position_sensor¿ 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.Case id (b)(4) confirmed the ¿bone model generation error¿ in the tibia bone removal screen, twice.This error is associated with a known software issue that has also been corrected in the release of cori 1.4.3.Case id (b)(4) confirmed a ¿robotic drill cable disconnected¿ error after the connection screen at the beginning of the case, then a ¿system console is bad¿ error message in the setup screen.The user then quit this case, where an ¿internal error¿ message was identified at the end of the case.The ¿robotic drill cable disconnected¿ error looks like it was triggered by a ¿tool_homing_failure¿.The ¿system console is bad¿ error message was confirmed and was triggered by a ¿drill current sense error,¿.Although the reported problem was not confirmed through a visual or functional evaluation, the analysis of submitted case files confirmed the reported errors.The most likely cause of these events 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 ¿internal error¿ identified at the end of the case is a likely occurrence of a known software issue.No errors were found in case id (b)(4).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 and that 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.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.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.

• Brand Name: REAL INTELLIGENCE CORI
• 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: 12096629
• MDR Text Key: 259600727
• Report Number: 3010266064-2021-00499
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757420
• UDI-Public: 00885556757420
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROB10024
• Device Catalogue Number: ROB10024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2023
• 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
• Patient Sequence Number: 1