MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FIGHTER SURETRAK II UNIVERSAL TRACKER, LARGE PASSIVE; INSTRUMENT, STEREOTAXIC

Model Number	961581
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.The array 961581 suretrak2 large passive (lot# 130424) was returned for analysis.Analysis found that the returned tracker was found to be in good condition with no apparent physical damage.The tracker was able to attach to a clamp without issue.With markers attached and fully seated, the tracker returned good geometry error with normal tracking.There was no fault found with the device.Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used outside a procedure.It was reported that the site had a damaged black suretrak.This was discovered during set-up and no patient was present.The orange surtrak was used instead.

• Brand Name: FIGHTER SURETRAK II UNIVERSAL TRACKER, LARGE PASSIVE
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8888087
• Report Number: 1723170-2019-04462
• Device Sequence Number: 205924
• Product Code: HAW
• UDI-Device Identifier: 00721902672309
• UDI-Public: 00721902672309
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2019

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: Health Professional
• Device Model Number: 961581
• Device Catalogue Number: 961581
• Device Lot Number: 130424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2019
• Initial Report FDA Received Date: 08/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1