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

Catalog Number ROB00079

Device Problem Application Program Problem: Parameter Calculation Error (1449)

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

Event Date 11/22/2022

Event Type  malfunction  

Manufacturer Narrative

Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.(b)(4).

Event Description

It was reported that during a navio-assisted tka procedure, the following error was displayed about three times "the system is unable to generate the bone model.Please recollect surface points", when surgeon touch the tibia cutting.The navio surgical system korea then return to the tibia mapping stage.When surgeon drew the tibia a little more, tibia cutting operated normally.Surgery was resumed after a non-significant delay, with the same device.Patient was not harmed.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6.The navio surgical system korea, part number rob00079, 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.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still within the product risk profile.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, the need for a corrective action is not 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 KOREA
• 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: 16010127
• MDR Text Key: 306100450
• Report Number: 3010266064-2022-00674
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ROB00079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2023
• 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: PFSR110137/NAVIO HANDPIECE