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

Catalog Number	961-578
Medical Device Problem Codes	Material Deformation (2976); Unintended Movement (3026)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been received by manufacturer for analysis.No further issues have been reported.
Event or Problem Description
A medtronic representative reported that, while in a planned maintenance (pm), found that the site's medium suretrak clamp slides, even with the screw all the way tightened.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, MEDIUM CLAMP
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 5978436
• Report Number: 1723170-2016-02362
• Device Sequence Number: 13627693
• Product Code: OLO
• UDI-Device Identifier: 00721902467714
• UDI-Public: 00721902467714
• 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
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 09/26/2016

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: 961-578
• Device Lot Number: 070727
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2016
• Initial Report FDA Received Date: 09/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1