MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) DRIVER 9735023 SOLERA 5.5/6.0 MAS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 9735024

Device Problems Bent (1059); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information was not made available from the site.Device manufacturing date is unavailable.Return requested for suspect solera driver 5.5/6.0 on 06/09/2016.No parts have been received by manufacturer for analysis.This device is included in the medical device field correction notification, "potential for instrument breaking ¿ medtronic navigated solera screwdrivers" (september 2015).The revised instructions for use (ifu) were also provided with the notification.

Event Description

A medtronic representative reported that, while in a posterior spinal fusion procedure, the site's screw driver was twisted / bent and became dysfunctional during implantation of navigated screws.Bent driver was replaced with a non-navigated version of the driver and the screws were placed accurately without issue.The surgeon opted to continue and completed the procedure with the use of the navigation system.Noted was that navigation worked perfectly.There was no delay of therapy reported.There was no impact on patient outcome.

• Brand Name: DRIVER 9735023 SOLERA 5.5/6.0 MAS
• 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: judith ericson ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 5770259
• MDR Text Key: 48816295
• Report Number: 1723170-2016-01286
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Relabeling
• Type of Report: Initial
• Report Date: 07/05/2016

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: 9735024
• Device Lot Number: 104719
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/06/2016
• Initial Date FDA Received: 07/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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