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

Model Number	ROB10026
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2023
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 surgery, after a successful calibration, test spin, and registration using the black foot pedal, the orange real intelligence foot pedal would not activate the robotic drill.Once the drill came into contact with the surface of the bone, it would expose, but it would not spin.New bur and new handpiece used and recalibrated, but the bur would not spin.The surgery was completed after a non-significant delay with manual instrumentation.Afterward, the foot pedal was tested with a kpc test and no errors displayed.The bur worked during diagnostics.No injuries were reported.
Additional Manufacturer Narrative
H10: additional information in d10.H3, h6.The real intelligence foot pedal, part number rob10026, serial number sn383, used for treatment was not returned for evaluation.An image was provided.The reported problem could not be confirmed with a visual inspection.Image only shows the passed kpc test.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.Refer to the real intelligence cori for knee arthroplasty user manual (500230 rev d) section 'understanding touch screen & foot pedal functionality' for proper handling.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.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with an intermittent connection to the console.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 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: 16985261
• Report Number: 3010266064-2023-00091
• Device Sequence Number: 6871683
• Product Code: OLO
• UDI-Device Identifier: 00885556757444
• UDI-Public: 00885556757444
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/12/2023

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 Model Number: ROB10026
• Device Catalogue Number: ROB10026
• 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: 05/01/2023
• Supplement Date Received by Manufacturer: 06/11/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 06/12/2023
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROB10024 / SN (B)(6).
• Patient Sex: Unknown