MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES CABLE, CAMERA CART, NAVIO; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 200028

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 09/02/2020

Event Type  Injury  

Event Description

It was reported that everything was alright during set-up.Before surgery a thunderbolt fell down to the hospital and the operation room was blackout.After a light came back, the operation was started.During a navio tka procedure, there was a beep sound coming from the camera even though the connecting sign was displayed on the screen.The beep sound and the error message "tracking failure" occurred when the screens of the prove recognition and the collection of femoral surface were displayed.The error message could not be removed so the procedure was changed to conventional bcs with a delay of 15 minutes.After procedure, it was confirmed that two of the pins of the camera cable were broken.No other complications were reported.

Manufacturer Narrative

H3, h6: the reported device (pn 200028), used in treatment, was returned to the designated complaint unit for independent evaluation.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review found similar reports, this issue will continue to be monitored.This failure mode is identified in the navio risk profile.The navio user's manual (500196) provides instruction for camera and camera cable setup, operation and troubleshooting.A relationship, if any, between the subject device and the reported event could be determined.Investigation confirmed that there were broken pins in the connector and the cable was damaged.This damage would have caused the reported tracking failures, which are most likely due to intermittent connections.No containment or corrective actions are recommended at this time.Please review the user manual and surgical technique for proper care and handling of the device.The medical investigation found that per complaint details, following an electrical storm/o.R.Blackout, the operation was initiated and the device malfunctioned with a camera error during the procedure.Per field report, the surgeon abandoned the navio and changed to a conventional bcs with a delay of 15 minutes with no patient injury.Reportedly, the alternate procedure was successful; therefore, additional interventions were not required, and no patient harm resulted.Reportedly, it was noted post-operatively that the root cause was 2 broken pins of the camera cable.Photos were provided and reviewed, however, the broken pins are not easily identifiable in the image.Patient impact beyond the reported use of the manual instrumentation to conclude the procedure would not be anticipated as per the complaint and field report, no patient injury resulted from the conventional procedure or the 15 minute surgical delay.No further medical assessment is warranted at this time.

• Brand Name: CABLE, CAMERA CART, NAVIO
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10610359
• MDR Text Key: 209335841
• Report Number: 3010266064-2020-01806
• Device Sequence Number: 1
• Product Code: OLO
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 200028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Date Manufacturer Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention