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

Catalog Number	ROB10024
Medical Device Problem Code	Application Program Problem: Parameter Calculation Error (1449)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that, during a cori assisted tka surgery using one (1) real intelligence cori, after prepping femur distal bur punch size 9 5in cutting guide, the surgeon went to bur all and felt that the bur cut too deep on the anterior chamfer cut.Surgeon downsized to 8 and finished the cuts with manual block.The surgeon was happy with x-rays.Tracking arrays did not move.Additional anesthesia was not necessary.The procedure was resume, after a non-significant delay, with a change in surgical technique (manual procedure).No further complications were reported.
Additional Manufacturer Narrative
The real intelligence cori, part number rob10024, serial number (b)(6), used for treatment was not returned for evaluation, therefore a device analysis was unable to be performed.The clinical/medical investigation concluded that based on the screenshot context and the session log sequence, this adverse event was likely a user error during femur checkpoint verification which likely failed due to the checkpoint distance threshold limit being exceeded, which means there was movement/shift in the trackers.It was noted that the procedure was completed with a non-significant delay with a change in the surgical technique to manual a procedure with no further complications and a downsizing of the implant.Screenshots and system log files provided were reviewed with the software support team; the reported problem of system malfunction during cutting was not confirmed.Although the overcut is visible in the screenshots, there is no evidence of software faults, handpiece errors, or abnormal system behavior.The logs show two invalid calibration events early in the procedure that were resolved after recalibration, followed by a checkpoint verification failure caused by exceeding the checkpoint distance threshold.Which indicates tracker movement resulting in user-induced positioning error.A complaint history review was performed by part number and similar complaints were identified.A review by lot/serial number was performed and no similar complaints were identified.A review of manufacturing records indicate 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.The most likely cause of this event is associated with an user-induced positioning error.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: 24215458
• Report Number: 3010266064-2026-00024
• Device Sequence Number: 8579641
• Product Code: OLO
• UDI-Device Identifier: 00885556757420
• UDI-Public: 885556757420
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2026

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 04/07/2026
• 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