MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC S7; INSTRUMENT, STEREOTAXIC

Model Number	9731780
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 there were some instruments that were damaged and need to be replaced.No patient was present at the time of the event.
Additional Manufacturer Narrative
The returned instrument udi, 510k # and manufacturer date were updated to the returned instrument.The open spine clamp was returned to the manufacturer for evaluation.After functional testing and visual/physical examination the reported issue was confirmed.The adjustment screw threads were damaged and there were tool marks around the head of the screw of the returned clamp.Physical damage was observed.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 there were some instruments that were damaged and need to be replaced.No patient was present at the time of the event.

• Brand Name: S7
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8147692
• Report Number: 1723170-2018-06165
• Device Sequence Number: 19172185
• Product Code: HAW
• UDI-Device Identifier: 00643169308879
• UDI-Public: 00643169308879
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K990214
• 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,Followup
• Report Date (Section B): 01/10/2019

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: 9731780
• Device Catalogue Number: 9731780
• Device Lot Number: 151016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1