MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) SURETRAK II UNIVERSAL TRACKER, MEDIUM CLAMP; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 961578

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 11/03/2016

Event Type  malfunction  

Manufacturer Narrative

Return requested.Replacement suretrak2 clamp medium shipped to site (b)(4) 2016.Medtronic investigation of returned suspect suretrak2 clamp medium finds that clamp adjustment screw head is somewhat rounded out causing difficulty setting the clamp.The clamp is otherwise functional.Physical damage rounded head/damaged screw hardware investigation was completed.This issue was found related to a hardware issue and was documented in a medtronic hardware anomaly tracking database.

Event Description

A site purchasing department representative reported that their suretrak2 medium clamp was damaged.No further details regarding the damage, or how it occurred, were provided.There was no patient present when this issue was identified.

Manufacturer Narrative

The device was returned for analysis and not repaired and returned.(b)(4) was inadvertently selected.

• Brand Name: SURETRAK II UNIVERSAL TRACKER, MEDIUM CLAMP
• Type of Device: NEUROLOGICAL 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 80027-9710 ; 7208902338
• MDR Report Key: 6141157
• MDR Text Key: 61409342
• Report Number: 1723170-2016-05604
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00721902672279
• UDI-Public: 00721902672279
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 961578
• Device Lot Number: 140528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2014
• 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