MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE 24 IN. TOUCH SCREEN; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	ROB10003
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a cori assisted surgery, the real intelligence 24 in.Touch screen blacked out and turned completely off before calibration but popped back on before burring of distal femur.The procedure was completed using the tablet for calibration and until monitor came back on during planning screen.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
The cori touchscreen pn rob10003, sn (b)(6), used in treatment, was not returned for evaluation.A visual and functional evaluation could not be performed and a relationship between the reported event and the device could not be determined.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 has identified prior events.No reasonable contributing factors could be identified based on the received complaint information and investigation results.A historical escalation event review was not completed.The product was not returned and no evidence was made available to link the complaint to an escalation event.Refer to the cori user manual to the recovery procedure guidelines section that provides guidelines for recovering to a fully manual procedure in the event of an unrecoverable hardware failure.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Per complaint details, no patient injury or impact was reported and there was no intervention necessary due to the reported event.Smith & nephew has not received adequate materials to fully evaluate the complaint, but if additional relevant materials are later received the complaint can be reopened.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: REAL INTELLIGENCE 24 IN. TOUCH SCREEN
• 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: 12316484
• Report Number: 3010266064-2021-00601
• Device Sequence Number: 14496306
• Product Code: OLO
• UDI-Device Identifier: 00885556756256
• UDI-Public: 00885556756256
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K193120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2022

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: ROB10003
• Device Catalogue Number: ROB10003
• 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: 07/29/2021
• Supplement Date Received by Manufacturer: 02/21/2022
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 02/22/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown