MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE 6 MM CYLINDRICAL BUR; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	ROB10036
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a cori-assisted tka, while tibial burr, the real intelligence 6 mm cylindrical bur stopped spinning and got free from the real intelligence robotic drill.The femur cut was fine.The affected drill did not accept a new burr, and visually the initial burr end tip connection fractured got stuck into it.Surgery was performed after a non-significant delay, with a back-up device.No patient complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
The real intelligence 6 mm cylindrical bur, part number rob10036, lot number 51063086, used for treatment was not returned for evaluation.A video was provided.The reported problem was confirmed with a visual inspection.A visual inspection of the video and images was conducted and confirmed a piece of the bur broke off.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing records indicate 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.The most likely cause of this event is associated with mechanical failure of the drill locking mechanism.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 6 MM CYLINDRICAL BUR
• 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: 17368150
• Report Number: 3010266064-2023-00129
• Device Sequence Number: 19779298
• Product Code: OLO
• UDI-Device Identifier: 00885556757512
• UDI-Public: 885556757512
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2023

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: ROB10036
• Device Lot Number: 51063086
• 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: 07/03/2023
• Supplement Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 08/21/2023
• Date Device Manufactured: 09/04/2022
• 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, SERIAL: (B)(6); REAL INTELLIGENCE ROBOTIC DRILL, SERIAL: (B)(6)
• Patient Sex: Unknown