MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) NAV CD HORIZON SOLERA MAST 4.75 DRIVER; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 9734856

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2017

Event Type  malfunction  

Manufacturer Narrative

No parts have been received by manufacturer for evaluation.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.Part not returned for evaluation.

Event Description

A medtronic representative reported that during a spinal fusion procedure the tip of the solera driver was bent.Site continued the use of instrument and completed the procedure.Medtronic representative suspected that the reported issue occurred while the instrument was in the patient anatomy.The procedure was completed with the use of navigation.There was no delay to the procedure.No impact on patient outcome.

Manufacturer Narrative

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.

• Brand Name: NAV CD HORIZON SOLERA MAST 4.75 DRIVER
• Type of Device: NEUROLOGICAL 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 ; 7208902515
• MDR Report Key: 6849770
• MDR Text Key: 85167563
• Report Number: 1723170-2017-03663
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169045040
• UDI-Public: 00643169045040
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• 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: Relabeling
• Type of Report: Initial,Followup
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9734856
• Device Lot Number: 131007
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2013
• 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: 47 YR
• Patient Weight: 86