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

Catalog Number	ROB10024
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a real intelligence cori assisted tka surgery, during the femur bone removal, the cori screen went black for few seconds, after return of the screen an error message appeared on screen about drill deactivated.After 3 unsuccessful attempts to reinitialize the drill, another back up drill have been used with the same result.The procedure was resumed, after a non-significant delay, with manual procedure.No further complications were reported.
Additional Manufacturer Narrative
H3, h6: the real intelligence cori, part number rob10024, serial number (b)(6), intended for treatment was returned for evaluation.The reported problem could not be confirmed with a visual inspection.Nothing was visually identified that leads to the reported scenario.The reported problem was not confirmed with a functional evaluation.A test case was performed using a known to work drill.The setup was completed as intended.On the burring phase no failures occurred.The test case was completed without any failures occurring.The console was opened for further investigation.The connections were checked.All were in place.A second technician was asked to confirm the reported scenario.A second test case was performed which could be completed without any failures occurring.A third test case was performed using a different known to work drill.Again, the test case was completed without any failures occurring.A complaint history review was performed by part number, and similar complaints were identified.A review by serial number was performed and no similar complaints were identified.A review of manufacturing records indicates the device met all specifications upon release into distribution.The failure mode and associated risk have been anticipated within the risk file, and the documented risk level is still adequate.A historical review concluded that no prior escalation actions are applicable to the scope of the reported complaint.We have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.No reasonable contributing factors could be identified based on the received complaint information and investigation results.Based on the investigation, no containment or corrective action is recommended or required at this time.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 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 24221513
• Report Number: 3010266064-2026-00025
• Device Sequence Number: 8392681
• Product Code: OLO
• UDI-Device Identifier: 00885556757420
• UDI-Public: 885556757420
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K193120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ROB10013, SERIAL NUMBER UNKNOWN
• Patient Sex: Unknown