MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO FLAT MARKERS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	PFSDV0016
Medical Device Problem Codes	Nonstandard Device (1420); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a cori assisted tka procedure, there were some issues with visualization.The navio flat markers were cleaned off, but during burring they were flickering very consistently.The procedure was completed, after a significant delay.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
The navio flat markers, part number pfsdv0016, lot number unknown, used for treatment was not returned for evaluation, therefore a device analysis was unable to be performed.A complaint history review for similar reported/confirmed complaints has identified prior events.While all products meet required manufacturing specifications prior to release a serial number, lot number, part revision or software version is required to link the device to a dhr or nc investigation.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.A historical review concluded that the lot, serial number or part number reported in this event is related to a corrective/preventive action.We have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with software settings.As part of corrective action, a software change will update the image settings to optimize flat marker detection.Smith & nephew has initiated a field action to voluntarily correct the cori surgical system.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.H10- additional information d10 concomitant medical products h11- corrected data b5 - describe event or problem.
Event or Problem Description
It was reported that, during a cori-assisted tka, there were some issues with visualization.The navio flat markers were cleaned off, but during burring they were flickering very consistently.The procedure was completed, after a delay greater than 30 min, with the same robotic instrumentation.Patient was not harmed as consequence of this problem.

• Brand Name: NAVIO FLAT MARKERS
• 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: 19021492
• Report Number: 3010266064-2024-00075
• Device Sequence Number: 18127507
• Product Code: OLO
• UDI-Device Identifier: 00885556628904
• UDI-Public: 00885556628904
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K152574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PFSDV0016
• Device Lot Number: UNKNOWN
• 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: 03/13/2024
• Supplement Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 05/21/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: REAL INTELLIGENCE CORI: ROB10024,SN (B)(6).
• Patient Sex: Unknown