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

Catalog Number NPFS02000

Device Problems Overheating of Device (1437); Unintended Application Program Shut Down (4032)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/15/2023

Event Type  Injury  

Manufacturer Narrative

Internal reference: (b)(4).

Event Description

It was reported that during a navio-assisted tka, there was air coming out of the drill connection on the navio.This eventually stopped/lessened.It was mapped and planned the case and as moved forward to cut it was received an internal cab one/drill console error.The case was quitted, resumed, swapped the drill - which also noticed was oscillating - made it to the cut screen and received the same error.At this point the anspach control completely shut down and was unrecoverable.Unit was rebooted and the anspach did not initialize so could not proceed.Surgeon decided to finish the case manually after a non-significant delay.No patient complications were reported.

Manufacturer Narrative

The navio surgical system us, part number npfs02000, serial number (b)(6), used for treatment was not returned for evaluation.An image was provided.The reported problem was confirmed with a visual inspection.The image of the error indicates that the anspach console has lost communication with the system.The images also indicate the anspach console is behaving erratically; the front panel display is of, then displays all segments.A log file assessment was completed.The reported problem was confirmed.The log files identify the anspach console failure and error.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.If a navio¿ surgical system failure occurs at any point during the surgical case, refer to the surgical technique guide for knee arthroplasty, recovery procedure guidelines tables for proper guidance regarding 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.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.A historical review concluded that no prior escalation actions are applicable to the scope of the reported complaint.The most likely cause of this event is associated with an internal failure of the anspach console.The anspach console is an oem device and further root cause cannot be determined.Based on the investigation, no containment or corrective action is 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.

Manufacturer Narrative

The navio surgical system us, part number npfs02000, serial number (b)(6), used for treatment was returned for evaluation.An image was provided.The image of the error indicates that the anspach console has lost communication with the system.The images also indicate the anspach console is behaving erratically; the front panel display is off, then displays all segments.The reported problem could not be confirmed with a visual inspection of the actual device.The reported problem was confirmed with a functional evaluation.The console was inserted into a known functioning navio system.The console would oscillate on and off.It has experienced a catastrophic failure and will not function.The log files identify the anspach console failure and error.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.If a navio¿ surgical system failure occurs at any point during the surgical case, refer to the surgical technique guide for knee arthroplasty, recovery procedure guidelines tables for proper guidance regarding 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.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.A historical review concluded that no prior escalation actions are applicable to the scope of the reported complaint.The most likely cause of this event is associated with an internal electronic failure of the console.Based on the investigation, no containment or corrective action is 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.

• 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
• 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: 16994008
• MDR Text Key: 315861445
• Report Number: 3010266064-2023-00097
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628416
• UDI-Public: 885556628416
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/05/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2023
• Initial Date FDA Received: 05/24/2023
• Supplement Dates Manufacturer Received: 07/18/2023; 09/04/2023
• Supplement Dates FDA Received: 07/19/2023; 09/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1