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

Catalog Number	ROB10013
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a real intelligence cori assisted tka surgery, it was noticed that the internal carriage of a real intelligence robotic drill was completely blocked, and it was impossible to engage the bur.The procedure was resumed, without any delay, changing to a manual procedure.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.When prompted to unlock the drill a system timeout occurred.This occurred every time the drill was unlocked.A kpc test was performed.There it was noticed that the burr could not be loaded.The drill was opened for further investigation.The think purple and transparent wires were squeezed.The exposure motor diodes were measured and passed.A hipot test was performed which failed as both motors had a to high current.The motors were removed and the drill was inspected further.It was noticed that the inside of the drill had liquid ingress and was full of residue.It was attempted to remove the carriage.It could not be pushed out by hand.The carriage had to be pressed out.The carriage was covered in a thick film of residue.Alot of residue buildup was found around the internal o-ring 101778.The carriage was opened for further investigation.It was full of residue.The carriage was disassembled further.Both bearings were full of residue and did not turn.The front bearing had broken and fell apart when removing the bearings from the collet shaft.All seals were inspected.No damages or abnormalities were found.The housing displays no sign that the liquid came through the cable as a result op the torn of slip shaft.A complaint history review was performed by part number and similar complaints were identified.A review by serial number was performed and no 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 component failure due to liquid ingress, as no other defects were observed in the seals and gaskets, the liquid ingress may have been a result of improper handling during cleaning and sterilization activities.Another cause is the residue buildup around the carriage preventing the drill from fully unlocking.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: 24268496
• Report Number: 3010266064-2026-00031
• Device Sequence Number: 21337444
• 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): 03/11/2026

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: 01/22/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 03/11/2026
• 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: ROB10024, SERIAL NUMBER (B)(6).
• Patient Sex: Unknown