MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC SURETRAK2 MEDIUM CLAMP; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	961-578
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.No parts have been 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 a procedure.It was reported that the clamp had a connection failure.There was no patient present when this issue was observed.On (b)(6) 2018, galip2 received following response from (b)(6).If the instruments pass verification or could they have passed verification? could not be obtained.The provided information has been confirmed with the physician/account: yes or no yes.
Additional Manufacturer Narrative
The clamp was returned to the manufacturer for analysis.Analysis found that the returned clamp was well worn but otherwise fully functional.No problem found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURETRAK2 MEDIUM CLAMP
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8064664
• Report Number: 1723170-2018-05630
• Device Sequence Number: 950209
• Product Code: OLO
• UDI-Device Identifier: 00721902467714
• UDI-Public: 00721902467714
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2018

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: 961-578
• Device Catalogue Number: 961-578
• Device Lot Number: 160404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1