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

Model Number ROB10024

Device Problem Connection Problem (2900)

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

Event Date 04/27/2022

Event Type  Injury  

Event Description

It was reported that, as the surgeon began to bur the femur in a cori assisted tka surgery, a drill disconnect error occurred.They checked the real intelligence robotic drill and it was plugged in just fine.They hit continue on the error screen, and it happened again.They hit continue and it happened again.When they tried disconnecting the drill and swapping to a new one, the bur, the real intelligence robotic drill tracker and the ri robotic drill attachment were locked onto each other and they could not get them off the real intelligence robotic drill.As they did not have another drill tracker to attach on the backup drill, they had to complete the surgery with manual instruments.Also, it is suspected that the cori may be the problem.The patient had a positive outcome.No significant delays were reported.

Manufacturer Narrative

Internal complaint reference (b)(4).

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 console is bad¿ error messages in the femur cut screen.The log files show that this error message was a result of a recoverable error: ¿tool_homing_failure.¿ because the error was recoverable, the user was able to select ¿continue¿ on the screen multiple times.As found in the visual inspection of the drill attachment, the detached retaining nut was a likely obstruction preventing the exposure motor¿s ability to fully extend and/or retract the carriage.This is the most likely cause of the ¿tool_homing_failure¿ errors that resulted in the ¿system console is bad¿ error messages in the femur cut screen.This obstruction within the drill attachment likely prevented the carriage from getting to the position within the drill that allows the removal of the drill attachment.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 and that the documented risk level is still adequate.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
• 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: 14467712
• MDR Text Key: 292371628
• Report Number: 3010266064-2022-00380
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757420
• UDI-Public: 00885556757420
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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?: Yes
• Device Operator: Health Professional
• Device Model Number: ROB10024
• Device Catalogue Number: ROB10024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2022
• Initial Date FDA Received: 05/23/2022
• Supplement Dates Manufacturer Received: 08/09/2022
• Supplement Dates FDA Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: ROB10014 REAL INTELLIGENCE ROBOTIC DRILL TRACKER; ROB20000 CORI ROBOTICS USA
• Patient Outcome(s): Required Intervention; Other