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

Model Number	BI-700-00027-120
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2016 a medtronic representative, following-up at the site, confirmed screws on trackers were damaged not the clamps themselves.Return requested for suspect clamp/screws.No parts have been received by manufacturer for analysis.
Event or Problem Description
A medtronic representative reported that, while in a spine procedure, a site's suretrak2 medium passive clamp had stripped screws.No further details regarding the damage, how or specifically when it occurred, were provided.The surgeon opted to continue and completed the procedure with the use of the navigation system.Delay in therapy was less than one hour.There was no impact on patient outcome.

• Brand Name: FIGHTER SURETRAK II UNIVERSAL TRACKER, MEDIUM PASSIVE
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 5998166
• Report Number: 1723170-2016-02479
• Device Sequence Number: 671720
• Product Code: HAW
• UDI-Device Identifier: 00721902672293
• UDI-Public: 00721902672293
• 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): 10/04/2016

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: Physician
• Device Model Number: BI-700-00027-120
• Device Catalogue Number: 961579
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2016
• Initial Report FDA Received Date: 10/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1