MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE FOOT PEDAL; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	ROB10026
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during the femur mapping stage in a cori assisted surgery, the error "foot pedal cable disconnected" popped on screen.After resetting the foot pedal connection, the error "pedal cable disconnected" appeared during the femur cut stage.The surgery was completed with manual instrumentation with a significant delay.The patient was not harmed beyond the reported problem.
Additional Manufacturer Narrative
H3, h6: the real intelligence foot pedal, part number rob10026, serial number (b)(6), used for treatment was not returned for evaluation, therefore a device analysis was unable to be performed.The software files were downloaded from the device and provided for investigation.When the foot pedal is connected a voltage spike is generated, the log files show a voltage above the normal which results in a error.The symptoms relating to the problem can be compared to bug 1973.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 real intelligence cori for knee arthroplasty user manual (500230 rev d) provides guidelines for recovering to a fully manual procedure in the "recovery procedure guidelines, appendix d".The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still within the product risk profile.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 a software bug.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 FOOT PEDAL
• 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: 14132549
• Report Number: 3010266064-2022-00300
• Device Sequence Number: 16713534
• Product Code: OLO
• UDI-Device Identifier: 00885556757444
• UDI-Public: 00885556757444
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2023

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: ROB10026
• Device Catalogue Number: ROB10026
• 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: 03/22/2022
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 04/18/2022
• Supplement Report FDA Received Date: 02/20/2023
• 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: ROB20000/CORI ROBOTICS USA/SN (B)(6)
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Unknown