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

Catalog Number	ROB10013
Medical Device Problem Codes	Break (1069); Failure to Calibrate (2440); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a cori assisted tka, at calibration step, the burr of one (1) real intelligence robotic drill was not spinning.Additionally, it failed the set maximum speed test.The procedure was resumed, without any delay, with a change in surgical technique to manual procedure, as no back up was available.No further complications were reported.
Additional Manufacturer Narrative
H3.H6: the real intelligence robotic drill, part number rob10013, serial number (b)(6), intended for treatment was returned for evaluation.The reported problem could not be confirmed with a visual inspection.The external condition shows moderate signs of wear.Nothing was visually identified that leads to the reported scenario.The reported problem was confirmed with a functional evaluation.A kpc test was performed.The burr did not spin.The motor was heard running.Random exposure mode failed.The drill was opened for further investigation.It was noticed that the motors had residue around them.A hipot test was performed and the exposure motor failed.The motors were removed.It was nearly impossible to remove the exposure motor.The threads of the housing were corroded and damaged.The extension shaft had broken.The carriage had a little amount of residue around it.The carriage was opened and it was noticed that the front had liquid ingress.A complaint history review was performed by part number and similar complaints were identified.A review by serial number was performed and similar complaints were identified.A review of manufacturing records indicates 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 extension shaft.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: 24499663
• Report Number: 3010266064-2026-00046
• Device Sequence Number: 18632084
• Product Code: OLO
• UDI-Device Identifier: 00885556757321
• UDI-Public: 885556757321
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K201022
• 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): 04/16/2026

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
• Date Returned to Manufacturer: 02/20/2026
• 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: 03/27/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/16/2026
• 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: REAL INTELLIGENCE CORI, PN: ROB10024, SN: (B)(6).
• Patient Sex: Unknown