MAUDE Adverse Event Report: NAVINETICS NAVINETICS REUSABLE STEREOTACTIC SYSTEM; STEREOTACTIC DEVICE

Model Number	NN1000
Medical Device Problem Codes	Use of Device Problem (1670); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report was submitted late due to technical issues with the esg.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Navinetics became aware of a case where the patient was scheduled for awake bilateral dbs lead implantation (stage i) using the navinetics stereotactic system for navigation and instrument delivery, with the ipg/battery implantation (stage ii) to occur five days later.The navinetics skull anchor key was attached to the patient's skull using the tools provided with the system.The physician reported the skull anchor key was secure and the procedure continued.After the leads were placed, an intraoperative x-ray using the provided reticles was taken and the leads appeared on target.The surgical team reported feeling confident the implantation was sufficient (as indicated by adequate intraoperative physiological response from the patient) and therefore the surgical wounds could be closed.A post implant ct scan was taken; the ct fiducial box was noted to be securely attached to the key.The post implant ct scan showed that both dbs leads were >2mm above target but roughly along their trajectory.Due to satisfactory intraoperative physiological response from the patient, the lead placement error was initially attributed to the lead anchoring mechanism and deemed acceptable.The patient was sent to recovery and no adverse effects were observed.After the procedure, it was noted that the screws securing the skull anchor key were easy to remove.Subsequent review of the preoperative and post implant ct scans indicated two of the four screws securing the skull anchor key were no longer seated in the skull at the time of the post implant ct scan.It was reported that the surgical staff later determined the lead placement should be adjusted at the patient's stage ii procedure.At the stage ii procedure, the cranial wounds were reopened and the leads were adjusted appropriately (without the use of stereotactic equipment), the wounds were closed.An additional ct scan confirmed adequate lead adjustment.The patient is reported to be doing well and experiencing no adverse effects from the additional adjustment.The reported malfunction is >2mm performance error, and movement of the skull anchor key screws.While no adverse events were observed in this case, unintended screw movement and potential target inaccuracy exceeding 2mm could pose the risk of serious injury to the patient if the event were to recur.At the time of this report the cause of the malfunction is undetermined.Submission of this report does not constitute an admission of the product, medical personnel, user facility, or manufacturer caused or contributed to this event.
Event or Problem Description
In the initial report navinetics became aware of a case with >2mm performance error, and movement of the skull anchor key screws.While no adverse events were observed in this case.An investigation was conducted and determined the cause of the malfunction was a deviation in the instructions for skull anchor key application resulting in insufficient securement, movement of the skull anchor key and subsequent target inaccuracy.
Additional Manufacturer Narrative
Device evaluation and investigation revealed the device was performing as intended and the reported malfunction resulted from user error in method of skull key application.

• Brand Name: NAVINETICS REUSABLE STEREOTACTIC SYSTEM
• Common Device Name: STEREOTACTIC DEVICE
• Manufacturer (Section D): NAVINETICS; 206 south broadway; suite 700; rochester MN 55904
• Manufacturer (Section G): NAVINETICS; 206 south broadway; suite 700; rochester MN 55904
• Manufacturer Contact: danielle jondal ; 206 south broadway; suite 700; rochester, MN 55904 ; 5073613576
• MDR Report Key: 15753351
• Report Number: 3023194190-2022-70001
• Device Sequence Number: 2958945
• Product Code: HAW
• UDI-Device Identifier: 10850023620078
• UDI-Public: 10850023620078
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K210700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2022

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 Model Number: NN1000
• Device Catalogue Number: NN1000
• Device Lot Number: 331806122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MEDTRONIC DBS SENSIGHT LEADS,; MEDTRONIC DBS SENSIGHT LEADS,
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White