MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAVLOCK UNIVERSAL GREEN TRACKER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9734734
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis on the returned green tracker resulted in a physical damage failure being found through functional testing and visual/physical examination.Analysis stated that, one of the side tabs is broken at the tip causing the reported loose fit for inserted instruments.Otherwise, with markers attached and fully seated, the tracker returned a good geometry error.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 of procedure.It was reported that the instrument trackers were bad upon receiving.The violet track is missing a sphere post and the green tracker has loose locking mechanism so instruments are not staying properly attached.There was no patient present when this issue was identified.

• Brand Name: NAVLOCK UNIVERSAL GREEN TRACKER
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8103067
• Report Number: 1723170-2018-05843
• Device Sequence Number: 1733863
• Product Code: OLO
• UDI-Device Identifier: 00643169101968
• UDI-Public: 00643169101968
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 11/26/2018

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: 9734734
• Device Catalogue Number: 9734734
• Device Lot Number: 150813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 11/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1