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

Catalog Number PFSDV0016

Device Problem Nonstandard Device (1420)

Patient Problem Laceration(s) (1946)

Event Date 02/26/2024

Event Type  Injury  

Manufacturer Narrative

Internal reference number: (b)(4).H10: smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.

Event Description

It was reported that during a cori assisted tka surgery, the handpiece tracker began to flicker when the bur was started.The flickering became extreme very quickly and caused the bur to take too much bone on the distal femur.The camera was pointed directly at the flat markers and there was no blood on them.When held at various angles, they would be seen perfectly.The silver was not dull and they did not look visually damaged.When all the flatmarkers were changed, the tracker was seen.There was no issue with the tracker itself.The procedure was performed, without any delay, using a s+n back-up device.Patient was not harmed as consequence of this problem.

Manufacturer Narrative

H2: additional information ¿h6: health effect - impact code¿.H3, h6: the navio flat markers, part # pfsdv0016, lot # 23hk00179, intended for use in treatment, was returned for evaluation.The exterior condition shows no wear.Nothing was identified visually that contributed to the reported problem.A functional evaluation was completed.The reported problem was confirmed.The flat markers will flicker when placed approximately 1.5 meters from the camera and held approximately perpendicular to the camera.A review of the provided system logfiles was performed with the software team.The reported problem was confirmed.The log files confirm that during the checkpoint verification stage, the tracker was not visible, which resulted in a timeout during the checkpoint collection.It was however, not shown where any tracker errors or robotic drill errors were received.Notably, no tracker information logs were found during the femur cutting process.The cori system software was shown to have functioned as intended.A review of the provided screenshots was performed with the clinical support team.The reported problem was confirmed, the screenshots showed that there was an overcut on the distal femur.It is also shown that the femur tracker was not visible on the femur bone removal screen.The rep stated verbally that the system displayed the "too fast" icon and surgical technique most likely contributed to the gouging.The most likely cause of this event is due to software settings.A review of manufacturing records indicates the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints found similar events.A historical escalation event review was completed.The review determined that prior escalation actions are applicable to the part number or serial number and scope of this complaint, and no further escalation action is required.Refer to the real intelligence cori for knee arthroplasty user manual (500230 rev d), section attaching flat markers, ensure that each flat marker is seated fully.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Per complaint details the tracker(s) began to flicker when the bur was started.The flickering became extreme very quickly and caused the bur to take too much bone on the distal femur.The field report documents the flickering flat trackers ¿caused the bur to take too much bone on the distal femur¿ and also shows an equipment swap was necessary; however, impact on the case is documented as ¿none¿.It was reported that the trackers did not look visually damaged and would work intermittently when ¿held at various angles¿.Reportedly the patient was not harmed as consequence of this problem, but it is unknown how the event (over burred distal femur) was treated, if at all.The device problem was confirmed per product evaluation and actions have been initiated to mitigate future similar events.As of the date of this clinical/medical investigation no further information/documentation has been provided.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.The device problem was confirmed per the product evaluation and actions have been initiated to mitigate future similar events: as part of corrective action, a software change will update the image settings to optimize flat marker detection.The patient impact includes the unspecified amount of over-burring/¿too much bone¿ removed from the distal femur (although it is unknown how or if the over-burring was treated) along with the reported equipment swap/use of backup device(s) to complete the procedure without delay.Further impact cannot be determined based on the limited information provided.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.The failure mode will continue to be monitored through complaint investigation and trended through post market surveillance activities.

• Brand Name: NAVIO FLAT MARKERS
• 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: 18937009
• MDR Text Key: 338068341
• Report Number: 3010266064-2024-00064
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628904
• UDI-Public: 00885556628904
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/14/2024

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 Catalogue Number: PFSDV0016
• Device Lot Number: 23HK00179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2024
• Supplement Dates Manufacturer Received: 05/13/2024
• Supplement Dates FDA Received: 05/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ROB10024/REAL INTELLIGENCE CORI.