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

Catalog Number	961-584
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been received by manufacturer for evaluation.Part not returned for evaluation.
Event or Problem Description
A site representative reported that while outside of surgery the tip of the clamp driver was outworn.There was no patient present at the time of the issue.

• 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: 6902828
• Report Number: 1723170-2017-03958
• Device Sequence Number: 16258704
• Product Code: HAW
• UDI-Device Identifier: 00721902467660
• UDI-Public: 00721902467660
• Combination Product (Y/N): N
• PMA/510(K) Number: K983670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2017

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: Physician
• Device Catalogue Number: 961-584
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2017
• Initial Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1