MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC SURGN CART 9735665 STEALTH S8 PREMIUM; INSTRUMENT, STEREOTAXIC

Model Number 9735665

Device Problem Imprecision (1307)

Patient Problems Spinal Column Injury (2081); Tissue Damage (2104)

Event Date 11/09/2018

Event Type  Injury  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that the system performed as intended, no hardware parts were replaced and there was no failure detected.The system then passed the system checkout and was found to be fully functional.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.The issue occurred intraoperatively during the navigate task and delayed the surgery by less than one hour.It was reported that in a minimally invasive case today the surgeon placed screws approximately 10 mm off from navigated placement.The site respun the patient and had to replace all of the screws.The site typically has the camera at the foot of the bed and places screws moving towards the reference frame, but for this case they had the camera at the head of the bed and placed their 6 screws (l3 to s1) moving away from the reference frame (attached at l3).The manufacturer representative informed site that reference frame movement was likely the cause.The surgery was completed with navigation.

Manufacturer Narrative

Software investigation found that the reported event was related to a software issue.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The event reported in this 3500a also represents a potential accidental radiation occurrence (aro) per 21 cfr 1002.20(a).Per 21 cfr 1002.20(c), this event is also being reported under part 803.Supplemental aro information is as follows: 3d dose absorbed (patient): 11.21msv (negligible) 1 - patient total number of people in or unknown.(b)(6).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A software investigation analysis was initiated to determine the probable cause of the issue through known anomaly determination.The software investigation found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURGN CART 9735665 STEALTH S8 PREMIUM
• 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: 8139114
• MDR Text Key: 129515979
• Report Number: 1723170-2018-06097
• 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,Followup
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• 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: 03/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 95