MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. NAVLOCK TRACKER UNIVERSAL VIOLET; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 9734682

Device Problems Device Issue (2379); Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2013

Event Type  malfunction  

Event Description

A medtronic representative reported that, while in a spine l4-s1 fusion procedure, the surgeon hammered on navlock with awl tip taps and the ratcheting small straight handle and violet navlock tracker universal were damaged.The navlock tracker itself was fine, however, the clips on the barrel no longer functioned properly.The surgeon completed the procedure with the use of the navigation system.There was no impact on patient outcome.

Manufacturer Narrative

Rma issued.Replacement violet navlock tracker universal had been shipped to the site previously.Medtronic investigation of returned suspect device finds that, as reported, the release tabs were stiff and not functioning properly.Otherwise, with markers attached and fully seated, the tracker returned a good geometry error.Mechanical failure, malfunction & wear, directly caused event.

• Brand Name: NAVLOCK TRACKER UNIVERSAL VIOLET
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 971
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 971
• Manufacturer Contact: judi ericson ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 3591866
• MDR Text Key: 4036446
• Report Number: 1723170-2014-00074
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/27/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9734682
• Device Lot Number: 120914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/27/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2012
• 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: 68 YR
• Patient Weight: 76