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

Model Number ROB10013

Device Problems Unstable (1667); Failure to Calibrate (2440); Connection Problem (2900)

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

Event Date 05/05/2021

Event Type  Injury  

Event Description

It was reported that, during a cori-assisted tka surgery, the swap bur button icon was pressed by accident as it is right next to the planning button.The case was sent back to the bur selection screen and the recalibrate step for the real intelligence robotic drill was necessary, then a calibration error message was displayed and was solved through troubleshooting.The case was exit and re-entered.Upon unlocking the drill a drill disconnect error message was displayed.The drill attachment was checked to see if it was fully looked and the case was exit, the drill was unplugged and plugged back in, the drill attachment was locked and the case was re-entered.A second drill disconnect error message was displayed when unlocking the drill for bur loading.After troubleshooting another drill disconnect error was displayed at the unlock screen (case-(b)(4)).It is unknown if this issue was caused by the real intelligence cori (case-(b)(4)).The drill was swapped, but the long attachment, tracker frame or the exposure guard were not swapped.At this point, the surgeon decided to finish the case with manual instrumentation.No significant delays (fewer than 30 minutes) were reported and the patient was not harmed.Additionally, after the case, the real intelligence robotic drill was assembled and when pressing unlock to load the burr, it was felt that the drill attachment rotated as if the unlocking mechanism of the drill caused the long attachment to rotate (case-(b)(4)).It is unknown if the drill attachment also contributed to this issue (case-(b)(4)).

Manufacturer Narrative

H3, h6: the real intelligence robotic drill, part number rob10013, serial (b)(6), and used for treatment, was returned for evaluation.A relationship between the reported event and the device was established.The reported problem could not be visually confirmed.A functional evaluation was performed.The reported problem was not confirmed.A kpc was performed and passed.A case was run and there were no calibration errors during the testing.There were no drill disconnect errors present during testing.A review of the patient case screenshots confirms the reported allegation of "drill disconnect" error.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.The most probable cause of the reported problem is to be determined.The real intelligence cori for knee arthroplasty user manual (500230) provides guidelines for recovering to a fully manual procedure in the "recovery procedure guidelines, appendix d".The reported incident was assessed from a clinical/medical standpoint: the surgeon decided to finish the case with manual instrumentation.No significant delays (fewer than 30 minutes) were reported and the patient was not harmed.This failure is an identified failure mode within the risk assessment released during the timeframe of the incident.Further investigation into the reported failure is being conducted via a capa to determine if additional actions are required.Additional information: d8/d9.

Manufacturer Narrative

Internal complaint reference: case-(b)(4.H3, h6: the real intelligence robotic drill, part number rob10013, serial (b)(6) and used for treatment, was returned for evaluation.A relationship between the reported event and the device was established.The reported problem could not be visually confirmed.A functional evaluation was performed.The reported problem was not confirmed.A kpc was performed and passed.A case was run and there were no calibration errors during the testing.There were no drill disconnect errors present during testing.A review of the patient case screenshots confirms the reported allegation of "drill disconnect" error.A review of manufacturing 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.Although the reported problem was not confirmed through a visual or functional evaluation, a review of patient case screenshots confirmed the reported problem.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.The real intelligence cori for knee arthroplasty user manual (500230) provides guidelines for recovering to a fully manual procedure in the "recovery procedure guidelines, appendix d".This failure is an identified failure mode within the risk assessment released during the timeframe of the incident.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.Additional information: g3/g4 (pma/510(k)number), h7, h8 corrected data: h6 (medical device problem code).

• 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: 11859510
• MDR Text Key: 260544452
• Report Number: 3010266064-2021-00396
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757321
• UDI-Public: 00885556757321
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ROB10013
• Device Catalogue Number: ROB10013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other