MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC SURETRAK2 MED PASS FGHTER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	961-579
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned to the manufacturer for analysis.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 site had discovered damaged instruments during sterile processing.The was noted that the probes are bent, the clamp screw is stripped and the reference frame is bent.There was no patient present when this issue was identified.

• Brand Name: SURETRAK2 MED PASS FGHTER
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8029099
• Report Number: 1723170-2018-05439
• Device Sequence Number: 1262403
• Product Code: OLO
• UDI-Device Identifier: 00721902467707
• UDI-Public: 00721902467707
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K983670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2018

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 Expiration Date: 11/06/2014
• Device Model Number: 961-579
• Device Catalogue Number: 961-579
• Device Lot Number: 120622
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 11/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1