MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE FOOT PEDAL; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number ROB10026

Device Problem Intermittent Communication Failure (4038)

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

Event Date 07/07/2022

Event Type  Injury  

Event Description

It was reported that the led on the real intelligence foot pedal connector of the console was blinking.On registration it was found that the real intelligence foot pedal was not getting detected.This was noticed during set up, and the procedure was performed, with a delay of less than 30 min, changing to a navio procedure.The patient was not harmed beyond the reported problem.

Manufacturer Narrative

Internal complaint reference (b)(4).

Manufacturer Narrative

D11: concomitant medical products and therapy dates.Section h3, h6: the real intelligence foot pedal, part number rob10026, serial number (b)(6), used for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.The clinical/medical investigation concluded that no patient injury was alleged due to the reported event.Patient impact beyond the reported 0-30 minute surgical delay, abandoning the cori for the navio¿ system could not be determined; however, the patient was reportedly not harmed beyond that which was reported.No further medical assessment could be rendered at this time.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing records indicate the device met all specifications upon release into distribution.Refer to the real intelligence cori for knee arthroplasty user manual (500230 rev d) page 23, section ¿beginning the intraoperative application¿, ¿connecting the tracking camera and foot pedal¿ for proper connection of the foot pedal the failure mode and associated risk have been anticipated within the risk file.The risk level is still adequate.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with an intermittent connection to the console.Based on the investigation, the need for a corrective action is not recommended or required at this time.Should any additional information be received the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.E1: name and address.

• Brand Name: REAL INTELLIGENCE FOOT PEDAL
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15108620
• MDR Text Key: 296652458
• Report Number: 3010266064-2022-00542
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757444
• UDI-Public: 00885556757444
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K193120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/13/2022

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 Model Number: ROB10026
• Device Catalogue Number: ROB10026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2022
• Initial Date FDA Received: 07/26/2022
• Supplement Dates Manufacturer Received: 10/12/2022
• Supplement Dates FDA Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: REAL INTELLIGENCE CORI, SN:(B)(6).
• Patient Outcome(s): Required Intervention