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

Catalog Number	ROB10013S
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference: (b)(4).
Event or Problem Description
It was reported that during a cori assisted tka procedure, when the real intelligence robotic drill was connected to the console, confirmation icon was flickering and the drill could not be recognized correctly.The customer re-connected the drill but the failure occurred again.Surgery was resumed after a 30-minute delay, with a change in surgical technique to navio assisted due to a back-up cori drill was not available.Patient was not harmed.
Additional Manufacturer Narrative
Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the ri robotic drill, part number rob10013, serial number (b)(6) , intended for use in treatment was returned for evaluation.A relationship between the reported event and the device was established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.Upon connection during a test case, the drill had a system time out error and then the confirmation icon rapidly flickered.Substituting the exposure motor with a test lab motor corrected the problem.An engineering review was completed.The reported problem was confirmed.The exposure motor encoder was tested and found to be unresponsive.The most likely cause of this event is a faulty exposure motor connection.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints found similar events.A historical escalation event review was completed.The review determined that prior escalation actions are applicable to the scope of this complaint and further investigation into the reported failure is being conducted to determine if additional escalation actions are required.Refer to the real intelligence cori for knee arthroplasty user manual, section setting up a cori knee procedure: setting up the instruments, connecting the robotic drill for proper set up and handling.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Per complaint details from japan, it was reported that during a cori assisted tka procedure, when the real intelligence robotic drill was connected to the console, confirmation icon was flickering and the drill could not be recognized correctly.The customer re-connected the drill but the failure occurred again.Surgery was resumed after a 30-minute delay, with a change in surgical technique to navio assisted due to a back-up cori drill was not available.Patient was not harmed.Further investigation into the reported failure is being conducted to determine if additional actions are required.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.

• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15500625
• Report Number: 3010266064-2022-00616
• Device Sequence Number: 1793102
• Product Code: OLO
• UDI-Device Identifier: 00885556780886
• UDI-Public: 885556780886
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2022

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 Catalogue Number: ROB10013S
• 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: 09/01/2022
• Supplement Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 09/28/2022
• Supplement Report FDA Received Date: 10/18/2022
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROB10024 REAL INTELLIGENCE CORI
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown