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

Catalog Number	ROB10027
Medical Device Problem Code	No Visual Prompts/Feedback (4021)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a cori assisted tka surgery, the real intelligence tablet's the touch screen activity was working, and the power green light was on, but the tablet screen was blank.No info visible was on the tablet screen.Cori system was restarted, unplugged and plugged tablet in, and no difference happened.Sterility risk was identified, by coming close to 24inch monitor to do planning screens.The procedure was resumed, after a significant delay, using the same device.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).Sections h3, h6 and h11 were updated.H11: results of investigation: the real intelligence tablet, part number rob10027, serial number (b)(6), intended for treatment was returned for evaluation.The reported problem could not be confirmed with a visual inspection.The tablet's external condition is acceptable and showed normal signs of wear.The lower left corner has got a bump so that the frame bent open.The connected cable assay has no cuts or nicks.The reported problem was confirmed with a functional evaluation.The tablet screen was connected to a known good cori tower with connected console, main screen, camera, drill and foot pedal.The screen powers up and the touch function is working but no image will be displayed.It was discovered that the cable on the inlet section must be broken or has loosen its connection to the tablet.The screen image will not be displayed and the connection led is off for a short time.A complaint history review was performed by part number, and no similar complaints were identified.A review by serial number was performed and no similar complaints were identified.A review of manufacturing and service 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 a broken wire on the cable inlet section.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 TABLET
• 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: 23693293
• Report Number: 3010266064-2025-00257
• Device Sequence Number: 18714156
• Product Code: OLO
• UDI-Device Identifier: 00885556757451
• UDI-Public: 885556757451
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 12/27/2025

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: ROB10027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 12/27/2025
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN: ROB10024 / SN: (B)(6).
• Patient Sex: Unknown