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 03/30/2016

Event Type  malfunction  

Manufacturer Narrative

Return requested for suspect solera driver 5.5/6.0.No parts were replaced.No parts have been received by manufacturer for analysis.No further issues have been reported.

Event Description

A medtronic representative reported that, while in an open navigated lumbar fusion spine procedure, the site's 5.5/6.0 driver was damaged.The engagement tip of 5.5/6.0 driver was splaying and appeared mushroomed as if the driver were being used as a tamp.This has not actually been the cause of the deformation of the tip, it is just what it looks like.The issue seems to be occuring from routine usage, cleaning, and sterilization.The deformation of the driver tip was reported to have been progressing over repeated use.The surgeon completed the procedure with the use of the navigation system.There was no delay of therapy.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: 5611569
• MDR Text Key: 43781412
• Report Number: 1723170-2016-00658
• 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
• Type of Report: Initial
• Report Date: 04/27/2016

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/30/2016
• Initial Date FDA Received: 04/27/2016
• 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
• Patient Sequence Number: 1