MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NDI CAMERA POLARIS SPECTRA; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number PFSR110137

Device Problems Device Difficult to Program or Calibrate (1496); Calibration Problem (2890)

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

Event Date 09/21/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case- (b)(4).

Event Description

It was reported that during a navio assisted surgery, the navio system was failing on registration after select bur stage into rotational access.It was not possible to get the navio handpiece past the full calibration phase, even after changing to a back up device.An error saying: "navio has detected problems with the tracking system.Full navio functionality will remain unavailable until this issue is resolved" was shown.The set up was conducted several times and after several attempts the decision was made to move to manual instrumentation.Patient was not harmed beyond the issue reported.

Event Description

It was reported that during a navio assisted surgery, the navio system was failing on registration after select bur stage into rotational access.An error saying: "navio has detected problems with the tracking system.Full navio functionality will remain unavailable until this issue is resolved" was shown on the screen, and they were unable to get the navio handpiece past the full calibration phase even after changing to a backup handpiece.So, they deciced to change the surgical technique and move to manual procedure as they were not confident if the ndi camera polaris spectra was causing the error.The procedure was completed without any delay and patient was not harmed beyond the issue reported.

Manufacturer Narrative

B5, d1, d4, h6.

Manufacturer Narrative

The device, ndi camera polaris spectra, part number pfsr200027, s/n (b)(6), used for treatment was not returned for evaluation, thus a visual and functional evaluation could not be conducted.A relationship between the reported event and the device was established.The reported problem was confirmed.A review of the customer provided log files confirmed the tracking system failure.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints found similar events.The most likely cause of this event is a component failure within the camera.A capa, hhe/pra, field action review was completed.A review of prior escalation actions found no actions applicable to the scope of the reported complaint.This failure is an identified failure mode within the risk assessment and the anticipated risk level is still adequate.If a navio¿ surgical system failure occurs at any point during the surgical case, the following table provides guidelines for recovering to a fully manual procedure.A failure can consist of, but is not limited to, a system software crash, unrecoverable hardware failure, handpiece failure with no backup available, tracker array failure or loss of contact with bone that is unrecoverable, etc.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.

• Brand Name: NDI CAMERA POLARIS SPECTRA
• 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: 12647104
• MDR Text Key: 276862448
• Report Number: 3010266064-2021-00719
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628515
• UDI-Public: 00885556628515
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PFSR110137
• Device Catalogue Number: PFSR200027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ROB00037-NAVIO SURGICAL SYSTEM SOUTH AFRICA; ROB00037-NAVIO SURGICAL SYSTEM (B)(6)
• Patient Outcome(s): Required Intervention