MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO SURGICAL SYSTEM US; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	PFSDV0016
Medical Device Problem Codes	Computer Operating System Problem (2898); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a navio-assisted procedure, the screen froze.They were unable to hit any buttons on touchscreen.Although the unit was rebooted, surgery was changed to manual instruments.Surgery was not delayed beyond 30 min.No other complications were reported.
Additional Manufacturer Narrative
H3, h6: the navio surgical system us (pn: npfs02000, sn(b)(6)), the cpu added as the concomitant product (pn: 220001), and the touchscreen used for treatment were not returned to the designated complaint unit for evaluation.The navio surgical system log files were not provided.Therefore, visual and functional inspections and log/case file assessments could not be performed, and the reported problem could not be confirmed.A review of manufacturing records indicate the software met all specifications upon release into distribution.A complaint history review found similar reports, this issue will continue to be monitored.Although the reported complaint could not be confirmed, a possible contributing factor for the frozen touch screen could be an issue with the cpu¿s video card, or another hardware/electrical failure within the cpu.Because the suspected product was not returned for evaluation, a functional inspection could not be performed to identify a root cause.Should a navio surgical system failure occur at any point during the surgical case, refer to the surgical technique guide for knee arthroplasty for guidelines for recovering to a fully manual procedure.A failure can consist of, but is not limited to, a system software crash, unrecoverable hardware failure, handpiece failure with no backup available, tracker array failure or loss of contact with bone that is unrecoverable, etc.This situation was captured in the navio risk assessment released at the time of the complaint.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: NAVIO SURGICAL SYSTEM US
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10437739
• Report Number: 3010266064-2020-01726
• Device Sequence Number: 2815903
• Product Code: OLO
• UDI-Device Identifier: 00885556628904
• UDI-Public: 00885556628904
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K191223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2021

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: PFSDV0016
• Device Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/29/2020
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKN NAVIO ROBOTICS INSTR.
• Outcome Attributed to Adverse Event: Required Intervention