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

Catalog Number PFSR200027

Device Problem Power Problem (3010)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/07/2017

Event Type  Injury  

Event Description

It was reported that equipment was set up before the case went completely fine.The camera connected and the handpiece was calibrated.While the surgeon made the incision and drilled bone pins, a "tracking failure" error came up on the screen.An error was dismissed on the screen but it did not resolve the issue.The camera was then unplugged from the side of the cart, but would still not connect.The camera was then unplugged and plugged back in from the back of the camera itself, but did not resolve.It was noted at this point that no lights were on the front of the camera.The case was restarted, but the camera still did not connect.The navio was restarted, internal connections checked and camera cord replaced but nothing resolved the issue.At no point did any lights illuminate on the camera itself, there was no power.The laser pointer still worked, but that is all.The case was aborted and the procedure was converted to manual.No patient injury was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device was used in treatment and was returned for investigation.Dhr review found that no conditions which could contribute to the reported event were identified.This information is reasonably suggesting that the device met the specifications at the date when it was released to the distribution.A complaint history found similar reports, this issue will continue to be monitored.The surgical system user's manual released at the time of the complaint (pn 500093 rev a) provides solution for the described camera error.This is an identified failure mode within the risk assessment.The investigation confirmed there was a relationship established between the reported event and the device.The device was returned and investigated for initial investigation.Based on the investigation the camera would not power on to connect to ndi tool box, nor would it connect to a navio system.The camera was returned to ndi for evaluation.The malfunction is most probably due to a component failure, supplier/raw material fault.No containment or corrective actions are recommended at this time.Per complaint details, the device malfunctioned during use and the navio was abandoned for manual instrumentation.Based on the information provided the modified procedure did not result in patientinjury/impact; therefore, no further medical assessment is warranted 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
• MDR Report Key: 9993670
• MDR Text Key: 188843462
• Report Number: 3010266064-2020-00385
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 07/10/2017
• Initial Date Manufacturer Received: 06/07/2017
• Initial Date FDA Received: 04/23/2020
• Supplement Dates Manufacturer Received: 07/29/2020
• Supplement Dates FDA Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR