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

Catalog Number	PFSDV0016
Medical Device Problem Codes	Nonstandard Device (1420); Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2024
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 surgery, the camera could not detect the navio flat marker.The procedure was performed, after a non-significant delay, using manual technique.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
H3, h6: the navio flat markers, part number pfsdv0016, lot number unknown, intended for treatment was returned for evaluation.The reported problem was confirmed with a visual inspection.The flat marker reflective disk was white and non reflective.The reported problem was confirmed with a functional evaluation.Attempting to use the flat marker on the tibia tracker caused the tracker to not be detected during setup.The flat marker was disassembled and it was found that the side of the disk that was installed downward was silver and reflective.The disk was flipped over and the flat marker was reassembled.After reassembly, the flat marker was now being recognized and the tracker was detected.The reported problem was confirmed.Disassembly of the flat marker found that the reflective disk was installed with the reflective side facing the opposite direction.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.A historical review concluded that the lot, serial number or part number reported in this event is related to a corrective/preventive action.According to document (b)(4), assy, flat marker, v-4000, navio rev a, states to place disk on the inner surface of top component with reflective gray side facing up.We do have reason to suspect that the product failed to meet any product specifications at the time of manufacture.The most likely cause of this event is associated with flat markers reflective material assembled with the reflective material flipped/upside down.As part of corrective action, continuous improvements have been made to the assembly process.The assembly work instruction will be updated to include a visual check using an infrared camera system that the operators can reference to confirm the reflective material is oriented correctly during flat marker assembly.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.Corrected data: h6 (medical device problem code).

• 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: 19080559
• Report Number: 3010266064-2024-00083
• Device Sequence Number: 12269433
• Product Code: OLO
• UDI-Device Identifier: 00885556628904
• UDI-Public: 00885556628904
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2024

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2024
• Supplement Date Received by Manufacturer: 04/21/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: PN: ROB10024 / SN: (B)(6).
• Patient Sex: Unknown