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

Model Number	961-581
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number and manufacture date not available on the date of filing.No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system.It was reported outside of a procedure that the screw thread of the large passive fighter was stripped and the product could not be fixed tightly.Another large passive fighter was used.There was no patient present.
Additional Manufacturer Narrative
The instrument was returned to the manufacturer for analysis.Analysis found the tracker was missing the attachment screw.Otherwise, with markers attached and fully seated, the tracker returned a good geometry error.Analysis found that the reported event was related to a mechanical issue.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FIGHTER SURETRAK II UNIVERSAL TRACKER, LARGE PASSIVE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8428516
• Report Number: 1723170-2019-01151
• Device Sequence Number: 18880283
• Product Code: OLO
• UDI-Device Identifier: 00721902672309
• UDI-Public: 00721902672309
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K983670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2019

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: 961-581
• Device Catalogue Number: 961-581
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 05/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1