MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) NAV CD HORIZON® LEGACY 5.5MM DRIVER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 9734274

Device Problem Bent (1059)

Patient Problem No Patient Involvement (2645)

Event Date 05/26/2015

Event Type  malfunction  

Event Description

A medtronic representative reported that during a spinal fusion procedure, a screwdriver became bent when placing a screw.The surgeon completed the procedure with the use of the navigation system.There was no impact on patient outcome.

Manufacturer Narrative

Device lot number, or serial number, unavailable.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.A medtronic representative, following up with the site, was informed by a site representative that the surgeon over-torqued the driver which caused it to get damaged.No parts have been received by the manufacturer for analysis.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Medtronic investigation of returned suspect device finds that as reported, the tip of the driver is twisted.Otherwise, the instrument is in good condition.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.The reported event was confirmed to be caused by physical damage of the instrument tip.As previously reported, a site representative stated that the surgeon over-torqued the driver which caused it to get damaged.Replacement device shipped to site for issue resolution.

Manufacturer Narrative

Correction: it was discovered on 27-jan-2016, that an incorrect date was referenced in a previous supplemental 3500a submission.The reported date of 16-aug-2016 was reported incorrectly and should be 16-aug-2015.Statement in previous supplemental 3500a submission should read: ¿on 30-jun-2015, it was noticed that a coding error in mdr submissions from our facility resulted in the maude database incorrectly coding the devices related to our mdr submissions from 25-may-2015 to 16-aug-2015.The decision to wait until the database was corrected was made after consultation with the fda as advised by a consumer safety officer with the information analysis branch, division of post market surveillance, office of surveillance and biometrics.An it solution was implemented on 16-aug-2015.This mdr was submitted to correct the coding error.There is no new information to change the patient information, event description and/or manufacturer narrative that was previously reported.¿.

• Brand Name: NAV CD HORIZON® LEGACY 5.5MM 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: kristianna bilan ; 826 coal creek circle; louisville, CO 80027 ; 7208902338
• MDR Report Key: 4856120
• MDR Text Key: 5805917
• Report Number: 1723170-2015-00735
• 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,company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/30/2015,02/18/2016

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: 9734274
• Device Lot Number: 110705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 07/30/2015
• Distributor Facility Aware Date: 07/06/2015
• Initial Date Manufacturer Received: 07/06/2015
• Initial Date FDA Received: 06/19/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 06/19/2015; 07/30/2015; 11/10/2015; 02/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2011
• 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
• Patient Age: 60 YR
• Patient Weight: 60