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

Catalog Number	ROB10013
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a tka, the real intelligence robotic drill wouldn't connect and unlock.The procedure was resumed, after a 5-minute delay, with a change in surgical technique.No further complications were reported.
Additional Manufacturer Narrative
H3, h6: the real intelligence robotic drill, part number rob10013, serial number (b)(6), used 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 confirmed with a functional evaluation.Kpc test was performed, the drill was responsive.The burr and drill attachment could be loaded as intended.The kpc test was continued.While the test was running the housing was lightly taped on.Random exposure and maximum retraction time failed.The kpc test was restarted.Again, when tapping the housing the test failed.The drill was opened for further investigation.The exposure motor was tested and passed.The motor cap for the exposure motor inspected.It was noticed that the insulation for the orange, gray and yellow cables was too short leaving the blank wires exposed over the cap.A kpc test was performed again while the drill was opened.The cable was slightly moved and it was found that the gray and orange wires were touching.Again, the test failed.The motors were removed and the drill was inspected further.No further defects were found.The cable was reworked and the drill was reassembled.A kpc test was performed during which the housing was tapped again.This time all test passed.A test case was performed which could be 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 a similar complaint was 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 short circuit caused by the motor wires touching due to a to short insulation.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 ROBOTIC DRILL
• 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: 24233161
• Report Number: 3010266064-2026-00027
• Device Sequence Number: 10188503
• Product Code: OLO
• UDI-Device Identifier: 00885556757321
• UDI-Public: 885556757321
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 03/10/2026

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: ROB10013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/10/2026
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN: ROB10024 / SN: (B)(6)
• Patient Sex: Unknown