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

Model Number NPFS02000

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/28/2020

Event Type  Injury  

Event Description

It was reported that during setup, the rep attempted to boot up the navio, but the touchscreen would not work.Had an external monitor hooked up and received the following error message ¿an error occurred during initialization: touchscreen communication compromised¿.Checked all connections and shutdown and rebooted six times with no change.After the case discovered the dvi cable is defective.Navio case aborted and completed with s+n manual instrumentation.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device was being used during treatment and was not returned for evaluation.There were also no photos returned of the device.There was no lot number provided for dhr review so it could not be concluded if the device met the manufacturing specifications.A complaint history review was performed and found 17 reports of the issue.This issue will continue to be monitored.The failure is identified in the risk profile.The surgical technique guide released at the time of the complaint (pn (b)(4) rev#d) provides instructions on how to recover to a fully manual procedure in the case the of a navio surgical system failure at any point during the surgical case.A failure can consist of, but is not limited, a system software crash, unrecoverable hardware failure, handpiece failure with no back available, tracker array failure or loss of contact with bone that is unrecoverable., etc.Since the reported event was related to a component failure, there is no indication in this complaint that the user did not follow the ifu.A relationship between the device and reported event has not been established.A factor that could have contributed to the reported event the dvi cable was defective.However, without the device for evaluation, the reported event cannot be confirmed.Therefore, the root cause of the reported event could not be determined.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.A review of this complaint case revealed there were no patient injuries reported.Since there was, no alleged harm to the patient, no further medical assessment is warranted at this time.

• Brand Name: NAVIO SURGICAL SYSTEM US
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 9999529
• MDR Text Key: 189086839
• Report Number: 3010266064-2020-01488
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628416
• UDI-Public: 00885556628416
• Combination Product (y/n): N
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

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
• Device Operator: Health Professional
• Device Model Number: NPFS02000
• Device Catalogue Number: RNPFS02000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 04/26/2020
• Supplement Dates Manufacturer Received: 01/28/2020
• Supplement Dates FDA Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention