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

Catalog Number	ROB10013S
Medical Device Problem Codes	Difficult to Insert (1316); Connection Problem (2900); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a real intelligence cori unknown type of surgery, many difficulties were encountered while attaching the milling cutter to one (1) real intelligence robotic drill.The system repeatedly displayed an error message during the calibration of the cutter, despite the trackers being in place and the pointer being in contact with the cutter.However, it was managed to proceed with the procedure, but during the cutting phase the cutter detached from the ri robotic drill.Afterwards, it was unable to reattach it.The procedure was resumed using a smith and nephew backup device, and no delay or injuries were reported as a result.
Additional Manufacturer Narrative
Internal complaint reference: case- (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 inherent device and/or procedural risks 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 conservatively 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 real intelligence cori tka surgery, many difficulties were encountered while attaching the milling cutter to one (1) real intelligence robotic drill.The system repeatedly displayed an error message during the calibration of the cutter, despite the trackers being in place and the pointer being in contact with the cutter.However, it was managed to proceed with the procedure, but during the cutting phase the cutter detached from the ri robotic drill.Afterwards, it was unable to reattach it.The procedure was resumed using an equivalent s+n back up product, and no delay or injuries were reported as a result.
Additional Manufacturer Narrative
Additional information was provided by the reporter.Sections b5, d10, e1, e2 and e3 were updated.Internal complaint reference: (b)(4).

• 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: 22936170
• Report Number: 3010266064-2025-00197
• Device Sequence Number: 13200460
• Product Code: OLO
• UDI-Device Identifier: 00885556780886
• UDI-Public: 885556780886
• 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): 09/11/2025

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: ROB10013S
• 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: 08/04/2025
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 09/11/2025
• 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: ROB10024, (B)(6).; REAL INTELLIGENCE CORI: ROB10024, UNKNOWN.
• Patient Sex: Unknown