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

Catalog Number ROB00036

Device Problems Computer Operating System Problem (2898); Connection Problem (2900)

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

Event Date 06/15/2023

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference: case (b)(4).

Event Description

It was reported that, during set-up for a navio assisted tka surgery, it was notices that the machine did not boot up.The error "reboot and select proper boot device or insert boot media".It is selected to "boot device and press a key" and also restarted the console, but still the error is persistent.The case was done manually with s+n instruments.Since the issue occurred during machine setup, patient was not involved yet.No injuries were reported.

Manufacturer Narrative

H10 - additional information: d10 - concomitant devices h11 ¿ corrected data.A1- please be aware that this field was intended to be in blank.B1 ¿ adverse event and product problem.B2 ¿ outcomes attributed to adverse event.B5- describe event or problem.H1 / h2 type of reportable event.H6- medical device problem code.

Event Description

It was reported that, during set-up for a navio-assisted tka surgery, it was noticed that the machine did not boot up.The error "reboot and select proper boot device or insert boot media" was shown.It was selected to "boot device and press a key" and the console was restarted as well, but still the error was persistent.The case was done manually with s+n instruments.No further complications were reported.

Manufacturer Narrative

The navio surgical system india, part number: rob00036, serial number: (b)(6), used for treatment was not returned for evaluation, therefore a device analysis was unable to be performed.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 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.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with console software bug.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 INDIA
• 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: 17264037
• MDR Text Key: 318560043
• Report Number: 3010266064-2023-00118
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556693506
• UDI-Public: 885556693506
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ROB00036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2023
• 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
• Treatment: 200509-CORVALENT COMPUTER.
• Patient Outcome(s): Required Intervention