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

Model Number	ROB10027
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a cori assisted tka surgery, when they connected the real intelligence tablet, both screens went black.They tried to disconnect and reconnect but the issue persisted.The procedure was completed by changing to manual procedure.Patient was not harmed beyond the problem reported.
Additional Manufacturer Narrative
H3, h6: the real intelligence tablet, (israel) rob10027, s/n (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.The tablet was connected to a console and advanced to a case.During evaluation, the tablet blackout was repetitive.The most likely cause of this event is esd interference and/or signal noise that causes the tablet to shut off to prevent current overload.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.The real intelligence cori for knee arthroplasty user manual provides guidelines for recovering to a fully manual procedure in the recovery procedure guidelines.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 israel, it was reported that during a cori assisted tka surgery, when they connected the real intelligence tablet, both screens went black.They tried to disconnect and reconnect but the issue persisted.The procedure was completed by changing to manual procedure.Patient was not harmed beyond the problem reported.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.
Additional Manufacturer Narrative
H3, h6: the real intelligence tablet, (israel) rob10027, s/n (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.The tablet was connected to a console and advanced to a case.During evaluation, the tablet blackout was repetitive.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 part number or serial number and scope of this complaint, and no further escalation action is required.The real intelligence cori for knee arthroplasty user manual provides guidelines for recovering to a fully manual procedure in the recovery procedure guidelines.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 israel, it was reported that during a cori assisted tka surgery, when they connected the real intelligence tablet, both screens went black.They tried to disconnect and reconnect but the issue persisted.The procedure was completed by changing to manual procedure.Patient was not harmed beyond the problem reported.The most likely cause of the reported issue is related to esd interference and/or signal noise which caused the tablet to shut off to prevent current overload.Initial changes were implemented with a firmware and cable update and additional corrective actions have been initiated.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.

• Brand Name: REAL INTELLIGENCE TABLET
• 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: 14493895
• Report Number: 3010266064-2022-00389
• Device Sequence Number: 14990212
• Product Code: OLO
• UDI-Device Identifier: 00885556757451
• UDI-Public: 00885556757451
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K193120
• Number of Events Summarized: 1
• Summary Report (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,Followup
• Report Date (Section B): 03/10/2025

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: ROB10027
• Device Catalogue Number: ROB10027
• 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: 05/02/2022
• Supplement Date Received by Manufacturer: 08/09/2022; 03/06/2025
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 08/10/2022; 03/10/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown