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

Catalog Number 200027

Device Problem Defective Component (2292)

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

Event Date 04/23/2019

Event Type  malfunction  

Event Description

It was reported that during the start of a tka procedure, the hip center was extremely difficult to collect.The lowest it could attain was 1.4.The case was continued.Once in the femur planning, something did not seem correct about what could be seen on the screen.Mainly the way the bone model presented and posterior femur condyles.The camera was checked and it was noticed the bump sensor light was on.The case was aborted due to the risk of having incorrect data collection.The procedure was performed manually instead.The investigation found camera was showing the error "camera infrared lamp is not working properly" which is related to an illuminator hardware fault.The bump sensor was not on, it was the orange led indicator.

Manufacturer Narrative

The device was intended for use in treatment and was returned for investigation.The dhr could not be reviewed and it was not confirmed if the product met manufacturing specifications.A complaint history found similar reports.The surgical system user's manual released at the time of the complaint provides solution for camera infrared 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.The returned camera was connected to the system and there was an error saying that the "camera infrared lamp is not working properly".The illuminator leds on the camera can go bad over time 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.The malfunction is most probably due to supplier / raw material fault.

• Brand Name: 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: 9993951
• MDR Text Key: 188840060
• Report Number: 3010266064-2020-00947
• 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: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 200027
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR