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

Catalog Number	ROB10024
Medical Device Problem Code	Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
H3, h6: the real intelligence cori, pn: rob10024, sn: (b)(6) used in treatment was not returned to the designated complaint unit for evaluation, therefore visual and functional evaluations could not be performed.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 drill and drill attachment were both 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 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 software 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.

• Brand Name: REAL INTELLIGENCE CORI
• Common Device Name: 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: 14403179
• Report Number: 3010266064-2022-00358
• Device Sequence Number: 12125567
• Product Code: OLO
• UDI-Device Identifier: 00885556773673
• UDI-Public: 885556773673
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K193120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2022

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ROB10024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 05/14/2022
• Supplement Report FDA Received Date: 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown