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

Catalog Number	ROB10013
Medical Device Problem Codes	Degraded (1153); Unstable (1667); Detachment of Device or Device Component (2907); Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a tka with the patient already under anesthesia, the real intelligence robotic drill manage to calibrate but failed during burring, even after troubleshooting.It couldn't even grab the bur correctly and it sunk into the drill.The procedure was resumed, after a non-significant delay, using an equivalent s+n back-up.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H3, h6: 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.
Additional Manufacturer Narrative
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.Nothing was identified visually that contributed to the reported problem.The reported problem was confirmed with a functional evaluation.Kpc/tka testing could not be performed due to the bur not loading to the drill.The housing, motors, and carriage were removed from the drill.There was a considerable amount of debris inside the drill housing and the main drill motor has a damaged slip shaft.In addition, the pin holding the shaft in place was loose inside the housing.The internal components of the carriage were inspected and there was debris inside the ball bearings and not rotating properly.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 service records indicate the device met all specifications following completion of the service activity.A historical review concluded that no prior escalation actions are 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.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 debris inside the housing and within the internal components, causing it to malfunction.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.
Additional Manufacturer Narrative
Internal reference number: (b)(4).H6 has been updated (g codes).

• 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: 23995515
• Report Number: 3010266064-2026-00003
• Device Sequence Number: 18697738
• Product Code: OLO
• UDI-Device Identifier: 00885556757321
• UDI-Public: 885556757321
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/23/2026

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: 01/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 03/19/2026; 03/19/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 03/23/2026; 03/23/2026
• 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
• Patient Sex: Unknown