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

Catalog Number NPFS02000

Device Problem Battery Problem (2885)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2020

Event Type  Injury  

Event Description

It was reported that, before a navio procedure, the system would not turn on.They tried multiple reboots, but it would not progress past the blinking icon.They confirmed that the power on both the system and cpu was on and that there were zero noticeable connection issues.The cart was plugged in overnight.The procedure was changed to manual instruments prior to the patient being in the room.No other complications were reported.

Manufacturer Narrative

G3, h2, h3, and h6: the navio surgical system (us), product npfs02000, (b)(6) intended for use in treatment was not returned for evaluation; thus, a visual and functional evaluation could not be performed, and a relationship between the reported event and the device could not be determined.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.Although the reported problem was not confirmed, a factor that may have contributed to the reported symptom may have been associated with battery failure.The navio surgical technique guide (500197) provides instructions on how to revert to a manual case from a system failure.This failure is an identified failure mode within the risk assessment.The medical investigation found that this complaint from the united states reports that before a navio procedure the system would not turn on.They tried multiple reboots but it would not progress past the blinking icon.The procedure was changed to manual instruments prior to the patient being in the room.No other complications were reported.No patient harm, injury or additional interventions were noted.Smith & nephew has not received operative reports, however the failure was identified before the patient was in the room and the decision to perform the procedure manually was made at this time.If additional clinically relevant materials are later received the complaint can be reopened.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• 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: 10813713
• MDR Text Key: 215472890
• Report Number: 3010266064-2020-01980
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628416
• UDI-Public: 885556628416
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention