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	09/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Event or Problem Description
It was reported that after a cori assisted tka surgery and while testing a new real intelligence robotic drill, it would not lock in a burr.Also, the real intelligence cori had a critical error and an internal error, and a system fault communication failure appeared on the screen.Since this happened after procedure, there was not patient involved.
Additional Manufacturer Narrative
Section h10: the real intelligence cori used for treatment was not returned to the designated complaint unit for evaluation.The real intelligence cori log files and/or case files were not provided to the designated complaint unit for evaluation therefore an assessment of the log files and/or case files could not be performed.However, pictures of the screen with the critical error, internal error, and system fault communication failure error were confirmed.The drill used in this case was returned.The functional evaluation found that the nosepiece of the drill was stuck on the o-ring, preventing the nosepiece from moving forward.Because the nosepiece could not move forward, the bur could not be inserted.The most likely cause of the system fault communication failure error and the subsequent internal error is a result of the drill¿s inability to move the nosepiece forward to insert the bur.The user does not say when the critical error occurred, but the most likely cause of the critical error is likely related to the functional issue of the drill.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.Internal complaint reference number: case-(b)(4).

• 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: 12610638
• Report Number: 3010266064-2021-00712
• Device Sequence Number: 4023927
• Product Code: OLO
• UDI-Device Identifier: 00885556773673
• UDI-Public: 885556773673
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K193120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ROB10024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 10/11/2021
• Supplement Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown