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

Catalog Number	961578
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.The suspect suretrak has been received by manufacturer for evaluation.The reported issue was confirmed as the head of the adjustment screw had tool marks and hex head is slightly rounded out allowing slippage of the tool.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.
Event or Problem Description
A site representative reported that while outside of procedure, a suretrak was damaged.There was no patient present at the time of the issue.

• Brand Name: SURETRAK II UNIVERSAL TRACKER, MEDIUM CLAMP
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6960199
• Report Number: 1723170-2017-04228
• Device Sequence Number: 10888947
• Product Code: HAW
• UDI-Device Identifier: 00721902467714
• UDI-Public: 00721902467714
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K983670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2017

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: 961578
• Device Lot Number: 141014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1