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

Catalog Number ROB00079

Device Problem Circuit Failure (1089)

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

Event Date 09/18/2022

Event Type  Injury  

Event Description

It was reported that, during a navio assisted tka procedure, while booting of the navio surgical system (b)(4) an error occurred.During initialization, the error message "pfs control hardware failure (errcode=40000000000)" appeared.Surgery was resumed after a non-significant delay, with a change in surgical technique to manual operation.The patient was not harmed beyond the reported problem.

Manufacturer Narrative

Internal complaint reference: case-(b)(4).

Manufacturer Narrative

Section h3, h6: the navio surgical system korea, part number rob00079, serial number (b)(6), used for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.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 navio surgical technique guide for knee arthroplasty (500197 rev c) provides guidelines for recovering to a fully manual procedure in the ¿recovery procedure guidelines¿.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.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with corrupt cpu bios settings.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: 15569264
• MDR Text Key: 301502444
• Report Number: 3010266064-2022-00624
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556725597
• UDI-Public: 885556725597
• Combination Product (y/n): N
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2022
• Is this an Adverse Event Report?: Yes
• 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: 11/13/2022
• 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: A
• Patient Sequence Number: 1
• Treatment: ASSY, PRGMMED, SIU, COMP CART, NAVIO
• Patient Outcome(s): Required Intervention