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

Model Number ROB10013

Device Problems Intermittent Continuity (1121); Connection Problem (2900); Noise, Audible (3273); Physical Resistance/Sticking (4012)

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

Event Date 04/19/2022

Event Type  Injury  

Event Description

It was reported that during a cori assisted tka surgery, when the surgeon began to mill the distal femur, the real intelligence robotic drill would make a loud screech.They checked the guard and the screech continued.They decided to swap the long attachment and hit the change burr icon, proceeded, and then received a drill communication error followed by an internal communication error.They went into drill diagnostics and could not dissemble the ri robotic drill attachment from the drill.The procedure was completed, with a non-significant delay, by changing to manual procedure.Patient was not harmed beyond the problem reported.

Manufacturer Narrative

H3, h6: the cori drill, pn: rob10013, sn (b)(6), used in treatment was returned for evaluation.The drill was visually and functionally evaluated and found, when disassembled, that the exposure motor lead screw was stuck.When attempting to test the drill, a critical error occurred.The drill attachment was also returned for evaluation, where no visual or functional abnormalities were identified.The software files were provided for investigation, where screenshot review of the case confirmed the ¿system fault: communication failure¿ error in the setup screen after having swapped the bur.The log files show that this error message was a result of an unrecoverable error where the drill ¿failed to reach ready state.¿ the stuck lead screw of the exposure motor is the most likely cause of the reported error.The real intelligence cori for knee arthroplasty user manual provides guidelines for recovering to a fully manual procedure in the "recovery procedure guidelines, appendix d".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 file will undergo further investigation by the site quality team.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review found similar reports.A review of prior escalation actions was performed and found no actions that are applicable to the scope of the reported complaint.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

H3, h6: the cori drill, pn: rob10013, (b)(6) , used in treatment was returned for evaluation.The drill was visually and functionally evaluated and found, when disassembled, that the exposure motor lead screw was stuck.When attempting to test the drill, a critical error occurred.The drill attachment was also returned for evaluation, where no visual or functional abnormalities were identified.The software files were provided for investigation, where screenshot review of the case confirmed the ¿system fault: communication failure¿ error in the setup screen after having swapped the bur.The log files show that this error message was a result of an unrecoverable error where the drill ¿failed to reach ready state.¿ the stuck lead screw of the exposure motor is the most likely cause of the reported error.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.The real intelligence cori for knee arthroplasty user manual provides guidelines for recovering to a fully manual procedure in the "recovery procedure guidelines, appendix d".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 device 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 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: 14403148
• MDR Text Key: 291730516
• Report Number: 3010266064-2022-00357
• 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: Company Representative
• Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2022
• 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: 04/27/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: RES# 93620
• Patient Sequence Number: 1
• Treatment: PN: ROB10014, LN: UNKNOWN
• Patient Outcome(s): Required Intervention