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

Model Number	ROB10027
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that before a cori assisted ukr procedure, the real intelligence tablet would remain constantly black, and the indicator light on the front of the tablet flashes green and orange alternately.The indicator light on the cori control unit lights up white all the time.Procedure continued with manual instruments, without a delay or injury.
Additional Manufacturer Narrative
H3, h6: the real intelligence tablet, part number rob10027, serial number (b)(6), intended for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.Log files although submitted would have no information to add to the investigation.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, section getting started: real intelligence¿ cori¿ quick start guide, connecting the components for proper set up and handling.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 tablet failure.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.Internal complaint reference number: (b)(4).
Additional Manufacturer Narrative
The real intelligence tablet, part # rob10027, serial # (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.Tests found that the touchscreen and backlighting of the tablet are functioning normally, but the video display is not receiving signal.The most likely cause is a faulty internal displayport connection for the tablet's screen or malfunctioning video board in the tablet.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.A review of prior escalation actions found no actions applicable to the scope of the reported complaint.Refer to the real intelligence cori for knee arthroplasty user manual, section getting started: real intelligence¿ cori¿ quick start guide, connecting the components 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.Although no further containment or corrective action is recommended or required at this time, the failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.Internal complaint reference number: (b)(4).

• 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: 14830692
• Report Number: 3010266064-2022-00508
• Device Sequence Number: 2367238
• Product Code: OLO
• UDI-Device Identifier: 00885556757451
• UDI-Public: 00885556757451
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 11/23/2022

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: ROB10027
• Device Catalogue Number: ROB10027
• 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: 06/08/2022
• Supplement Date Received by Manufacturer: 08/22/2022; 08/22/2022; 11/17/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 09/08/2022; 10/11/2022; 11/23/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown