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

Catalog Number	961-584
Medical Device Problem Codes	Material Deformation (2976); Naturally Worn (2988)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Device lot number is unavailable as the site discarded the suretrak2 clamp driver without documenting the lot number.Device manufacturing date is dependent on lot number, therefore, unavailable.Return requested for suspect suretrak2 clamp driver on 12/08/2016.12/28/2016 a medtronic representative, following-up at the site, reported the site stated that the suretrak2 clamp driver was more than 5 years old and believed the deformation problem to be from wear.This part was discarded by the site and will not be returned to manufacturer for analysis.
Event or Problem Description
A medtronic representative reported that a site has a stripped suretrak2 clamp driver.No further details regarding the damage, or how it occurred, were provided.There was no patient present when this issue was identified.

• Brand Name: SURETRAK® II UNIVERSAL TRACKER, CLAMP DRIVER
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6226979
• Report Number: 1723170-2017-00049
• Device Sequence Number: 1027699
• Product Code: HAW
• UDI-Device Identifier: 00721902467660
• UDI-Public: 00721902467660
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K983670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 01/05/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 961-584
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2016
• Initial Report FDA Received Date: 01/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1