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

Model Number ROB10024

Device Problems Intermittent Continuity (1121); Connection Problem (2900); Unintended Application Program Shut Down (4032)

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

Event Date 10/14/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during set up for a cori assisted tka surgery, the handpiece was plugged in and the real intelligence 24 in.Touch screen blacked.The monitor was already connected when the issue happened.They had reached the point of setup to plug in the handpiece, after the camera and foot pedal are shown to be connected, and after plugging in the handpiece, the screen flickered and blacked out, showing ¿no signal¿.All connections were checked; however, the monitor still read ¿no signal¿.The light in the corner of the monitor was orange instead of green.The procedure was completed, with a non-significant delay, by rebooting the system.Since incident occurred before procedure, patient was not involved.Upon investigation of the log files an abrupt shutdown of the system was identified.

Manufacturer Narrative

H3, h6: the real intelligence cori, part number rob10024, serial number (b)(6), intended for treatment was returned for evaluation.A relationship between the reported event and the device was established.The reported problem could not be confirmed with a visual inspection.The exterior showed minor wear (scratches, scuffs).Nothing was identified visually that contributed to the reported problem.The reported problem was not confirmed with a functional evaluation.The console was tested and it did not malfunction while under evaluation.There were no problems found with the hardware.The software files were downloaded from the device and provided for investigation.The log files confirmed the abrupt shutdown of the system.The most likely cause of this system shutdown is a known software issue.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.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 review concluded that no prior escalation actions are applicable to the scope of the reported complaint.The most likely cause of this event is associated with console software bug.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.

Manufacturer Narrative

H10: h3, h6: the real intelligence cori, part number rob10024, serial number (b)(6), intended for treatment was returned for evaluation.A relationship between the reported event and the device was established.The reported problem could not be confirmed with a visual inspection.The exterior showed minor wear (scratches, scuffs).Nothing was identified visually that contributed to the reported problem.The reported problem was not confirmed with a functional evaluation.The console was tested and it did not malfunction while under evaluation.There were no problems found with the hardware.The software files were downloaded from the device and provided for investigation.The log files confirmed the abrupt shutdown of the system.The most likely cause of this system shutdown is a known software issue.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.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.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 most likely cause of this event is associated with console software bug.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.H11: corrected data updated section h6 (medical device problem, component code, investigation findings and investigation conclusions).

• 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: 15569572
• MDR Text Key: 305351526
• Report Number: 3010266064-2022-00625
• Device Sequence Number: 1
• Product Code: OLO
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2022
• 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
• Date Returned to Manufacturer: 02/15/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• 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