MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NDI CAMERA POLARIS SPECTRA; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number PFSR200027

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 12/01/2020

Event Type  Injury  

Event Description

It was reported that during handpiece calibration step of navio tka procedure, the error "camera infrared lamp is not working properly.This may result in a limited field of view" popped on the screen.The amber led was also activated.The error persisted even after restarting the machine.The surgery was completed conventionally using smith & nephew manual instruments with a delay of fewer than 30 minutes.No other complications were reported.

Manufacturer Narrative

H3, h6: the ndi polaris camera, used in treatment, was returned for evaluation.There was a relationship between the device and the reported event.The medical investigation found that no patient injury resulted from the conventional procedure or the minor surgical delay.No further medical assessment is warranted at this time.Should clinically relevant documentation or information become available, the clinical/medical task may be re-evaluated.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review concluded this was a repeat issue.The navio user's provides instruction for camera setup, operation and troubleshooting.A review of risk management files found that the reported failure was documented appropriately.Visual inspection of the device revealed no discrepancies that may have contributed to the reported problem.A functional evaluation was performed and the camera event log was evaluated.The event log indicates multiple illuminator faults between (b)(6) 2019 to (b)(6) 2020.The camera was unable to connect to the calibration module.The unit was then connected to a known good navio system, which revealed that upon reaching the handpiece calibration stage, the error message present in the original complaint appeared.The complaint was confirmed.A factor that may have contributed to the reported complaint include: 1) the illuminator leds on the camera can go bad over time with use and cause floating "dead zones" in the camera view - this problem is physical in nature in the camera only and it needs to be serviced.No containment or corrective actions are recommended at this time.

• Brand Name: NDI CAMERA POLARIS SPECTRA
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 11076048
• MDR Text Key: 223711414
• Report Number: 3010266064-2020-02124
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556649541
• UDI-Public: 885556649541
• 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: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PFSR200027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Date Manufacturer Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention