MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 5.5/6.0 SOLERA DRIVER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 9735023

Device Problems Device Operates Differently Than Expected (2913); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2017

Event Type  malfunction  

Manufacturer Narrative

Patient weight not available from the site.No parts have been received by the manufacturer for evaluation.This device is included in the medical device field correction notification, "potential for instrument breaking ¿ medtronic navigated solera screwdrivers" ( (b)(6) 2015).The revised instructions for use (ifu) were also provided with the notification.Part not returned for analysis.

Event Description

A medtronic representative reported that, while in a t10-ilium due to degenerative disc disease procedure, the tip of the screwdriver being used separated from the driver.It was reported that the issue occurred when the surgeon was making final adjustments to the large screw for placement.No fragments of the device remained inside of the patient.There was no impact on patient outcome.There was no reported delay to the procedure due to this issue.No additional information was provided.

• Brand Name: 5.5/6.0 SOLERA DRIVER
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: peter verhey ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7123364
• MDR Text Key: 95073170
• Report Number: 1723170-2017-05146
• 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,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 12/15/2017

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
• Device Operator: Physician
• Device Catalogue Number: 9735023
• Device Lot Number: 131024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/22/2017
• Initial Date FDA Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-2823/2824-2015
• Patient Sequence Number: 1
• Patient Age: 76 YR