MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE 24 IN. TOUCH SCREEN; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	ROB10003
Medical Device Problem Codes	Computer Software Problem (1112); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during use of the cori system, data points continued to be collected even without the foot pedal being pressed.It is suspected that one (1) real intelligence 24 in.Touch screen may be causing the issue, resulting in the screen ¿sticking¿ during data collection.The procedure was resumed, after a non-significant delay, with a change in surgical technique (manual instrumentation).No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Device was evaluated.Sections h3, h6 (medical device problem code, component code, type of investigation, investigation findings and investigation conclusions) and h11 were updated.Internal complaint reference: (b)(4).H11: results of investigation: the real intelligence 24 in.Touch screen, part # rob10003, serial # (b)(6) used in surgery, was returned for evaluation.The external condition is like new.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed, and the reported problem was confirmed.A tka test case was performed.When pressing the footpedal and the touch screen at the same time during free collection, the points continue to be collected after releasing footpedal.The most likely cause of the reported problem is a known software defect.The gltk event handling ignores the pedal events once a "key view" is active (a key view is the view that the mouse/touchscreen presses on.And it's the view that takes all other mouse input : drag/release until the mouse button is released).The observed behavior confirms the way the gltk handles the events: the footpedal is pressed (event handled), the mouse is pressed (event creates a keyview), the footpedal is released (event is ignored, since there is already a keyview).A review of manufacturing and service records indicates the device met all specifications upon release into distribution.A complaint history review was performed by part number and no similar complaints were identified.A review by lot/serial was performed and no similar complaints were identified.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of the reported complaint.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Although no further containment or corrective action is recommended or required at this time, the failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.

• Brand Name: REAL INTELLIGENCE 24 IN. TOUCH SCREEN
• 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: 22332366
• Report Number: 3010266064-2025-00131
• Device Sequence Number: 8429419
• Product Code: OLO
• UDI-Device Identifier: 00885556756256
• UDI-Public: 885556756256
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 08/01/2025

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: ROB10003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 08/01/2025
• 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: REAL INTELLIGENCE CORI: ROB10024, SN (B)(6).
• Patient Sex: Unknown