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 Codes	Laceration(s) (1946); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a cori assisted tka surgery using one (1) real intelligence cori, plane visualizer was placed in cut slot for shark bite and after dialing in as close ¿0¿ or as close to plan, slope continuously would increase 3+ degrees from what was initially planned as pins were being placed into cut slot.It was decided to take a degree ¿less¿ from what was planned and after making tibial cuts with the saw, placed visualizer back on tibia and it showed surgeon took 8+ more of slope from plan.Then, it was attempted a clean-up cut with the bur to ensure it was accurate to plan and it showed it was deep on the medial side of the tibia.Then, dropped the tibia 1mm to ensure it had a flat surface.Once that cut was completed, the plane visualizer was placed back on the tibia to show where were according to plan and the reported console showed it was 8+ mm below plan.Finally, once trialing was began, postop rom and stressed gap check were taken.The gaps showed extremely loose medically and tighter laterally after we had planned to be close to 0 medially with about 2+mm of laxity laterally.It is unknown how the procedure was finished.The procedure was resumed after a significant delay.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known risks with the device itself or with its use that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, during a cori assisted tka surgery using one (1) real intelligence cori, plane visualizer was placed in cut slot for sharkbite, and after dialing in as close ¿0¿ or as close to plan, slope continuously would increase 3+ degrees from what was initially planned as pins were being placed into cut slot.It was decided to take a degree ¿less¿ from what was planned and after making tibial cuts with the saw, placed visualizer back on tibia and it showed surgeon took 8+ more of slope from plan.Then, it was attempted a clean-up cut with the bur to ensure it was accurate to plan and it showed it was deep on the medial side of the tibia.Then, dropped the tibia 1mm to ensure it had a flat surface.Once that cut was completed, the plane visualizer was placed back on the tibia to show they where according to plan, but the reported console showed it was 8+ mm below plan.Finally, once trialing was began, postop rom and stressed gap check were taken.The gaps showed extremely loose medially and tighter laterally after we had planned to be close to 0 medially with about 2+mm of laxity laterally.It is unknown how the procedure was finished.The procedure was resumed after a significant delay.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).Section b5, d4 and h6 were corrected.

• 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: 24476705
• Report Number: 3010266064-2026-00043
• Device Sequence Number: 21172428
• Product Code: OLO
• UDI-Device Identifier: 00885556757420
• UDI-Public: 885556757420
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/01/2026

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: 02/05/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/01/2026
• 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: ROB10025, SN: UNKNOWN.
• Patient Sex: Unknown