MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. SURETRAK II UNIVERSAL TRACKER, CLAMP DRIVER; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 961-584

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2014

Event Type  malfunction  

Event Description

A medtronic representative reported that, while in a spinal fusion procedure, a site's suretrak2 clamp driver was visibly damaged, bent.Damage was discovered after the procedure, when attempting to remove the clamps from the instruments.The surgeon tightened down the clamps onto the instruments, causing the screws to strip and the driver to bend.No further details were provided.Replacement instrument was requested.There was no delay in therapy.The surgeon completed the procedure with the use of the navigation system.There was no impact on patient outcome.

Manufacturer Narrative

Patient weight not made available from the site.Return requested.Replacement suretrak2 clamp driver shipped to site (b)(4) 2014.- no parts have been returned to manufacturer for analysis.

Manufacturer Narrative

Medtronic investigation of returned suspect device finds that the tip of the tool is severely twisted.The reported event was confirmed to be caused by physical damage.As previously reported, a replacement part shipped to site for issue resolution.

• Brand Name: SURETRAK II UNIVERSAL TRACKER, CLAMP DRIVER
• 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: kristianna bilan ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902338
• MDR Report Key: 4309968
• MDR Text Key: 5137502
• Report Number: 1723170-2014-01339
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983670
• 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,Followup
• Report Date: 11/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 961-584
• Device Lot Number: 130829
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2013
• 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: 38 YR