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

Model Number PFSDV0016

Device Problem Calibration Problem (2890)

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

Event Date 12/21/2020

Event Type  Injury  

Event Description

It was reported that, during a cori tka procedure, the case could not move forward past the calibration.It was verified that everything was assembled correctly, but even then the robotic drill would not calibrate due to a defective flat maker that seemed to not be sitting properly.Unfortunately, this was the last tray they had available for the day, so the case was completed with standard manual instrumentation with a delay of fewer than 30 minutes.After the robotic drill was taken off the field, they restarted the machine and tried to move through the calibration phase.That was when it was noticed one of the flat markers not be sitting properly.It was tried to snap it on further, but it was as far in as possible.That onew was swapped out and then were able to move past calibration.It seems that the flat marker was defective.

Manufacturer Narrative

H3, h6: the navio flat markers (united states), product: pfsdv0016, lot: 20kk00073 used in treatment were not made available to the designated complaint unit for evaluation, however visual inspection was possible with a photo.A relationship between the reported event and the device was not visually confirmed through the photo.A functional evaluation could not be performed because the device was not returned.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints concluded this was an isolated event.The root cause of the reported event could not be definitively concluded, however a user technique/variance could not be ruled out as a potential contributing factor to the reported event.Another contributing factor could be related to excess material that is evident in the photo on the other three prongs of the tracker frame leading to an insecure connection.Refer to the product user manual for "recovery procedure guidelines" that provides guidelines for recovering to a fully manual procedure in the event of an unrecoverable hardware failure.This failure is an identified failure mode within the risk assessment.The medical investigation found that this complaint from the united states reports that one of the flat markers seemed to be defective/not sitting properly.Based on the information provided, there was a small surgical delay because it was the last tray they had available for the day so the procedure was completed with manual instrumentation.No patient injury or impact was reported.Smith and nephew has not received adequate materials (operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received the complaint can be reopened.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 at a future date, this evaluation will be reopened for investigation.

Manufacturer Narrative

The navio flat markers, part number pfsdv0016, lot number 20kk00073, used for treatment was not returned for evaluation, therefore a device analysis was unable to be performed.An image was provided.The reported problem could not be confirmed with a visual inspection.The image does not confirm the flat marker not sitting properly.The clinical medical investigation performed does not provide any relevant additional information for the complaint.A complaint history review for similar reported/confirmed complaints concluded this was an isolated event.A review of manufacturing records indicate the device met all specifications upon release into distribution.Per the cori user manual (500230 rev d) note: "add the flat markers to the robotic drill tracker before attaching the robotic drill tracker to the robotic drill.Instructions: (2) support each tracker behind the flat marker attachment point and snap each flat marker onto each prong.(3) ensure each flat marker is seated fully¿.The root cause of the reported events could not be definitively concluded; however, a user technique/variance could not be ruled out as a potential contributing factor to the reported events.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 reported in this event is related to a corrective/preventive action.As this event is a known issue and already investigated in a corrective action, the product prints/specifications/procedure review task will not be performed.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with a non conforming material associated with the bottom part of the flat marker.As a part of corrective action a hardness test was implemented across all suppliers of flat marker housing parts.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.

• 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: 11144525
• MDR Text Key: 225996631
• Report Number: 3010266064-2021-00025
• 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: K193120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PFSDV0016
• Device Catalogue Number: PFSDV0016
• Device Lot Number: 20KK00073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention