MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE FEMUR TRACKER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	ROB10018
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a cori assisted surgery, while the surgeon was burring the distal femur, the real intelligence robotic drill started making a higher pitched noise and then just stopped and an error message was displayed.They got the real intelligence robotic drill switched out and continued on without issue.Other than that, at some point the real intelligence femur tracker moved and they were not able to continue with the robotics.It is unknown how the procedure was completed.The patient outcome is unknown.Additionally, the ri robotic drill attachment and; therefore, the real intelligence robotic drill tracker were locked on the handpiece and could not be removed.They all tried and even used pliers, it would not budge.
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
It was reported that, during a cori assisted surgery, while the surgeon was burring the distal femur, the real intelligence robotic drill started making a higher pitched noise and then just stopped and an error message was displayed.They got the real intelligence robotic drill switched out and continued on without issue.Other than that, at some point the real intelligence femur tracker moved and they were not able to continue with the robotics.The procedure was finished using an smith and nephew back up device.The patient was not harmed beyond the reported problem.Additionally, the ri robotic drill attachment and; therefore, the real intelligence robotic drill tracker were locked on the handpiece and could not be removed.They all tried and even used pliers, it would not budge.
Additional Manufacturer Narrative
The real intelligence femur tracker part number rob10018, used for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.A complaint history review for similar reported/confirmed complaints has identified prior events.While all products meet required manufacturing specifications prior to release a serial number, lot number, or part revision is required to link the device to a dhr or nc investigation.The real intelligence¿ cori¿ for knee arthroplasty user manual, preparing for the intraoperative knee procedure: setting up the bone hardware section provides guideline for proper installation of femur and tibia trackers.The failure mode and associated risk have been anticipated within the risk file.The risk level is still adequate.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with wear around the femur tracker splines.Based on the investigation, the need for a corrective action is not 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 FEMUR TRACKER
• 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: 13113227
• Report Number: 3010266064-2021-00918
• Device Sequence Number: 11664060
• Product Code: OLO
• UDI-Device Identifier: 00885556757376
• UDI-Public: 00885556757376
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ROB10018
• Device Catalogue Number: ROB10018
• 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: 12/13/2021
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 07/07/2022
• 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: CORI ROBOTICS USA / ROB20000; REAL INTELLIGENCE ROBOTIC DRILL TRACKER / ROB10014
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown