MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC 5.5/6.0 SOLERA DRIVER ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 9735024

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/30/2018

Event Type  malfunction  

Manufacturer Narrative

Patient weight not available. No parts have been returned to the manufacturer for analysis. 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 the driver broke during the case. The site used another driver to proceed in the case. There was a surgical delay of less than 1 hour due to this issue, and there was no impact on patient outcome.

Manufacturer Narrative

Initial reporters first name received. 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 the driver broke during the case. The site used another driver to proceed in the case. There was a surgical delay of less than 1 hour due to this issue, and there was no impact on patient outcome.

• Brand Name: 5.5/6.0 SOLERA DRIVER
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• 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: 8204671
• MDR Text Key: 131708142
• Report Number: 1723170-2018-06507
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/23/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 9735024
• Device Catalogue Number: 9735024
• Device Lot Number: 161105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/02/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/05/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse