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	Naturally Worn (2988)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.The damaged part was sent back to the manufacturer for part analysis.During part analysis it was found that the shaft of the driver was not secured to the handle.As a result, when pressure was applied, the shaft would spin within the handle.This issue was documented in a medtronic navigation hardware tracking database.
Event or Problem Description
A medtronic representative reported that the clamp driver was damaged and needed to be replaced.No patient was present during the time of the reported incident.

• 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: 6462382
• Report Number: 1723170-2017-01390
• Device Sequence Number: 18951578
• Product Code: HAW
• UDI-Device Identifier: 00721902467660
• UDI-Public: 00721902467660
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,user f
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 04/05/2017

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: Medical Equipment Company Technician/Representative
• Device Catalogue Number: 961-584
• Device Lot Number: 160712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2017
• Initial Report FDA Received Date: 04/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1