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

Catalog Number 9734274

Device Problems Bent (1059); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/25/2015

Event Type  malfunction  

Event Description

A medtronic representative reported that, while in a spine procedure, the navigated legacy driver shaft did twist when the surgeon was trying to take out a non-legacy screw.This was a revision procedure.No further details were provided.The surgeon completed the procedure with the use of the navigation system.There was no impact on patient outcome.

Manufacturer Narrative

Patient identifier not made available from the site.04/22/2015 a medtronic representative, following-up at the site, reported that the navigated legacy driver was mis-used with another screw system and the instrument was severely damaged.Return requested.Replacement device shipped to site 03/25/2015.No parts have been received by manufacturer for analysis.

Manufacturer Narrative

Medtronic investigation of returned suspect device finds that, as reported, the sleeve of the driver has been twisted and dented inward causing friction against the shaft of the instrument during rotation.The tip of the instrument is worn with slightly rounded edges.The reported event was confirmed to be caused by the physical damage of the driver.As previously reported the navigated legacy driver was mis-used with another screw system causing the physical damage.

Manufacturer Narrative

(b)(4).

• Brand Name: NAV CD HORIZON® LEGACY 5.5MM DRIVER
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 9710
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 9710
• Manufacturer Contact: kristianna bilan ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902338
• MDR Report Key: 4720040
• MDR Text Key: 5663286
• Report Number: 1723170-2015-00489
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K124004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative,company representati
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/19/2015,02/22/2016

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: 120910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 06/19/2015
• Distributor Facility Aware Date: 06/12/2015
• Initial Date Manufacturer Received: 06/12/2015
• Initial Date FDA Received: 04/22/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 06/19/2015; 11/10/2015; 02/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2012
• 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: 55 YR
• Patient Weight: 110