MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE TRACKING CAMERA; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number ROB10025

Device Problem Poor Quality Image (1408)

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

Event Date 10/28/2020

Event Type  Injury  

Event Description

It was reported that during cori tka procedure the probe and drill had poor visibility from none to flickering, during the burring and plane visualization steps of the procedure.Camera was aimed at the probe and drill, markers were pressed and cleaned, did not help.Surgeon began the femur cut with the bur but abandoned it due to this issue.It was difficult to check his cuts with the plane visualization tool, so he cut his tibia manually and checked his post-op gaps with the robot.Femur flickered in and out as well.No issues during registration.Sales rep wiped down the camera lenses with an alcohol prep pad and they had no issues in the two cases following.There were light smudge marks in the upper hemisphere of the lens.Delay reported less than 30 minutes.

Manufacturer Narrative

H3, h6: the real intelligence tracking camera, part number rob10025, serial unknown and used for treatment, was not returned for evaluation.A relationship between the reported event and the device could not be established.A visual/functional inspection cannot be completed as no device was returned for evaluation.Per the clinical evaluation of the reported incident completed on 22-dec-2020, no patient impact/harm/injury resulted from the reported events or the 0-30-minute surgical delay experienced, and the surgeon was satisfied with the procedure outcome.Reportedly, the cleansing of the camera-lens smudge marks resolved the reported visibility issue.Patient impact beyond the reported modified surgical procedure and the less than 30-minute surgical delay would not be anticipated as no patient injury was alleged due to the events and/or manual technique, which reportedly resulted in a satisfactory outcome.No further medical assessment can be rendered at this time.While all products meet required manufacturing specifications prior to release a serial number or lot number is required to link the device to a dhr or nc investigation, or field service report.A complaint history review for similar reported/confirmed complaints concluded this was an isolated event.While the reported problem was not confirmed during evaluation, the most probable contributing factor(s) to the reported problem is software issues.The cori surgical technique manual provides guidelines for recovering to a fully manual procedure in the ¿recovery procedure guidelines¿ section of ¿performing trial reduction and postoperative assessments this failure is an identified failure mode within the risk assessment released during the timeframe of the incident.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 or provided at a future date, this evaluation will be reopened for investigation.

• Brand Name: REAL INTELLIGENCE TRACKING CAMERA
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10863767
• MDR Text Key: 217070606
• Report Number: 3010266064-2020-02011
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757437
• UDI-Public: 00885556757437
• Combination Product (y/n): N
• PMA/PMN Number: K193120
• 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: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROB10025
• Device Catalogue Number: ROB10025
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ROB20000
• Patient Outcome(s): Required Intervention