MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE TUBING SET; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	ROB10031
Medical Device Problem Code	Inability to Irrigate (1337)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a tka surgery the irrigation didn¿t work during milling.The irrigation tubing was able to prime outside of the pump during milling, but once it was placed the tubing back within the pump there was no irrigation.The procedure was completed, without delay, using a bulb irrigation.It is unknown if this was a tubing or a console issue.No patient injuries and no other complications were reported.
Additional Manufacturer Narrative
H3, h6: the ri tubing set (us), rob10031, lot 50891743 used for treatment, was not returned for evaluation; thus, a visual and functional evaluation could not be performed, and a relationship between the reported event and the device could not be confirmed.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.A capa, hhe/pra, field action review was not completed.The product was not returned and no evidence was made available to link the complaint to a capa, hhe/pra, field action.Although the reported problem was not confirmed, a factor that may have contributed to the reported symptom may be associated with a mechanical component failure.Refer to real intelligence cori for knee arthroplasty user manual to the preparing the irrigation tubing section that provides guidelines for setting up the irrigation tube.This failure is an identified failure mode within the risk assessment.Per complaint details from the united states it was reported that during a cori assisted tka surgery, the irrigation didn't work during milling.The irrigation tubing was able to prime outside of the pump during milling, but once it was placed back in the pump there was no irrigation.The procedure was completed, without delay, using a bulb irrigation.No patient injuries and no other complications were reported.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 TUBING SET
• Common Device Name: 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: 11813031
• Report Number: 3010266064-2021-00360
• Device Sequence Number: 3766581
• Product Code: OLO
• UDI-Device Identifier: 00885556757468
• UDI-Public: 00885556757468
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K193120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2021

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
• Operator of Device: Health Professional
• Device Model Number: ROB10031
• Device Catalogue Number: ROB10031
• Device Lot Number: 50891743
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown