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

Catalog Number	ROB10016
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
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 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 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 cori assisted tka surgery, while finishing burring of tibia, the drill popped a connection error.It was able to recalibrate, but still real intelligence robotic drill guard spun and did not stay fixed to drill in place.Able to complete tibial cut with saw and created shelf.The surgery was completed after a non-significant delay.No injuries were reported.
Additional Manufacturer Narrative
Sections b5 and h6 (health effect - impact code) were updated.Section h10: additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that the procedure was finished with cori after they replaced the drill guard and there was no change in surgical technique, therefore, event may result in a short procedural delay and/or require use of a backup device to continue procedure.This event is not likely to cause or contribute to a death or serious injury and is considered not reportable pursuant to 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.Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a cori assisted tka surgery, while finishing burring of tibia, the drill popped a connection error.It was able to recalibrate, but still real intelligence robotic drill guard spun and did not stay fixed to drill in place.The drill guard had a noticeable defect and upon drilling it spun off, launched into the ceiling and back walk, and luckily did not land on the sterile field.Had irrigation tubing been available this would not have happened.The procedure was finished with cori after the drill guard was replaced.Able to complete tibial cut with saw and created shelf.The surgery was completed after a non-significant delay.No injuries were reported.

• Brand Name: REAL INTELLIGENCE ROBOTIC DRILL GUARD
• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 21627419
• Report Number: 3010266064-2025-00067
• Device Sequence Number: 8350601
• Product Code: OLO
• UDI-Device Identifier: 00885556757352
• UDI-Public: 885556757352
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K193120
• 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
• Report Date (Section B): 03/21/2025

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: ROB10016
• Device Lot Number: 1128360
• 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: 02/25/2025
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 03/21/2025
• 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, SN (B)(6).; REAL INTELLIGENCE ROBOTIC DRILL: ROB10013, UNKNOWN.
• Patient Sex: Unknown