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

Catalog Number	ROB10013
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during cori assisted tka surgery, the burr would not click in the real intelligence robotic drill.An error was received that burr was not fully seated, then, it was not operated with this handpiece.After the or, checked the handpiece, and it could not run any tests.Also, the ri robotic drill attachment could not be taken off anymore and was stuck on the handpiece.The procedure was resumed, after a significant delay, using an equivalent s+n back-up.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (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 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.
Event or Problem Description
It was reported that, during cori assisted tka surgery, the burr would not click in the real intelligence robotic drill.An error was received that burr was not fully seated, then, it was not operated with this handpiece.After the or, checked the handpiece, and it could not run any tests.Also, the ri robotic drill attachment could not be taken off anymore and was stuck on the handpiece.The procedure was resumed, after a 20 minute delay, using an equivalent s+n back-up.No further complications were reported.
Additional Manufacturer Narrative
H11: additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that there was a 20 minute delay instead of a delay greater than 30 minutes, therefore, a device or use problem that results in procedural delay of 30 minutes or less is not considered clinically significant, as it poses no additional risk to the patient.This event is not likely to require medical or surgical intervention to prevent a life-threatening illness or injury or permanent impairment of a body function or permanent damage to a body structure and is considered not reportable pursuant to the applicable regulations.If additional details confirm the occurrence of a reportable event, we will update our records accordingly and submit a subsequent report detailing both the event and our completed investigations.

• 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: 23900684
• Report Number: 3010266064-2025-00282
• Device Sequence Number: 5030480
• Product Code: OLO
• UDI-Device Identifier: 00885556757321
• UDI-Public: 885556757321
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 01/07/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 01/07/2026
• 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: ROB10015/SN(B)(6)/RI ROBOTIC DRILL ATTACHMENT.; ROB10024/SN(B)(6)/REAL INTELLIGENCE CORI.
• Patient Sex: Unknown