MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S8 PREMIUM SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number 9735665

Device Problem Imprecision (1307)

Patient Problems Complaint, Ill-Defined (2331); Iatrogenic Source (2498); No Known Impact Or Consequence To Patient (2692)

Event Date 01/31/2019

Event Type  Injury  

Manufacturer Narrative

A manufacturer representative went to the site to test the equipment.The navigation system passed the system checkout and was f ound to be fully functional.No parts on the system were replaced.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used for a sacroiliac and thoracolumbar procedure.It was reported that during a complex t4 to l3 fusion, the surgeon claimed 4 screws were inaccurately placed.The site used 2 spins with the frame placed on l3 and t9.Accuracy was verified with the passive planar probe.The screws on the cad model looked slightly off.It was noted that a knock-off driver was being used with knock-off screws.The patient had very small pedicles but the screws were relatively large.The screws were replaced with use of a c-arm.There was a surgical delay of less than 1 hour due to this issue, and there was no impact on patient outcome.

Manufacturer Narrative

A software analysis was initiated to determine the probable cause of the issue through reproducibility.Analysis was unable to determine probable cause without further information since the on-going investigation proved to be inconclusive based on the information provided.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A software analysis was initiated to determine the probable cause of the issue.Analysis found that the logs were reviewed and provided no additional insight into the alleged inaccuracy.Based on the case description that knock-off driver/screws were used, this is the likely cause.These tools are not supported by the stealth application (outside the use of suretrak, which was not used) and we cannot guarantee the accuracy of their driver.This is further supported by the fact that the passive planar was accurate while the screw placement was not.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION S8 PREMIUM SYSTEM
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8384350
• MDR Text Key: 137665373
• Report Number: 1723170-2019-00866
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169722187
• UDI-Public: 00643169722187
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9735665
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2018
• 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
• Patient Age: 21 YR
• Patient Weight: 59