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

Model Number ROB10013

Device Problems Failure to Calibrate (2440); Connection Problem (2900); Mechanics Altered (2984); Unintended Application Program Shut Down (4032)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/12/2023

Event Type  Injury  

Event Description

It was reported that, during a cori-assisted left tka procedure, the drill calibration process could not be completed.A real intelligence robotic drill (sn (b)(4)) did accept and secure the burr, but it then skipped the burr calibration screen (point probe slotted on handpiece) and jumped to the point probe/divot collection screen.Upon that collection an error message of ¿calibration verification error¿ appeared and kicked back to the resume operation screen.Multiple attempts were made with the same results.Two (2) other real intelligence robotic drills (sn (b)(4), sn (b)(4)) were then used with same results.The surgeon cancelled the case after multiple attempts to resolve the problem.Although no inicision had been made, patient was already under anesthesia.Patient was awoken and transferred to pacu.Impact to patient's health is yet to be determined.A drill diagnostic test was completed successfully after and the rep was able to properly calibrate drill sn (b)(4) on first attempt.At diagnosing, the rep was not able to calibrate drill sn (b)(4) initially.Error messages ¿communication failure¿ and ¿internal error¿ were displayed; then tried to run a drill diagnostic test but, upon selecting, the screen would go black for a second and error ¿robotic drill critical error¿ was displayed.After a few attempts, the rep was able successfully run a kpc test and passed.He then tried to calibrate again, was now able to start the process but, at collecting the point probe/divot collection at the very end, it would kick back to the resume operation screen.This handpiece could never be calibrated.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6: the real intelligence robotic drill, part number rob10013, serial number (b)(6), used 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.Completed a kpc test.Immediately received robotic drill critical error.Continued, kpc passed random exposure, failed remaining tests, received robotic drill critical error.Opened the assembly: evaluated exposure motor with multimeter and all tests pass.Swapped cable with a known good cable, no errors.Completed continuity test: identified the brown wire to the thermistor is open below the thermistor solder connection.Removed the cable from the drill and identified a break in the brown thermistor wire just inside strain relief.The most likely cause is a damaged conductor in the drill cable.A complaint history review for similar reported/confirmed complaints concluded this was an isolated event.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.Refer to the real intelligence cori for knee arthroplasty user manual, section assembling the robotic drill for proper set up and handling.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.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

The real intelligence robotic drill, part number rob10013, serial number (b)(6), used 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.Completed a kpc test.Immediately received robotic drill critical error.Continued, kpc passed random exposure, failed remaining tests, received robotic drill critical error.Opened the assembly: evaluated exposure motor with multimeter and all tests pass.Swapped cable with a known good cable, no errors.Completed continuity test: identified the brown wire to the thermistor is open below the thermistor solder connection.Removed the cable from the drill and identified a break in the brown thermistor wire just inside strain relief.The most likely cause is a damaged conductor in the drill cable.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.A complaint history review for similar reported/confirmed complaints concluded this was an isolated event.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.Refer to the real intelligence cori for knee arthroplasty user manual, section assembling the robotic drill for proper set up and handling.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.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 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: 16325416
• MDR Text Key: 309060642
• Report Number: 3010266064-2023-00020
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201022
• 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
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2023
• Initial Date FDA Received: 02/08/2023
• Supplement Dates Manufacturer Received: 03/09/2023; 02/08/2024
• Supplement Dates FDA Received: 03/10/2023; 02/09/2024
• 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: A
• Removal/Correction Number: RES# 93620
• Patient Sequence Number: 1
• Treatment: ROB10013 / (B)(6); ROB10013 / (B)(6); ROB10024 / (B)(6)
• Patient Outcome(s): Hospitalization