MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC DRILL GUIDE 9732355 VMAX CANNULATED; INSTRUMENT, STEREOTAXIC

Model Number	9732355
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Initial reporter, unknown at the time of filing.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation instrument outside of procedure.It was reported that the drill guide was damaged and missing its handle.No patient was present.
Additional Manufacturer Narrative
The drill guide was returned to the manufacturer for evaluation.The guide was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Initial reporter updated.If information is provided in the future, a supplemental report will be issued.

• Brand Name: DRILL GUIDE 9732355 VMAX CANNULATED
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8818420
• Report Number: 1723170-2019-04195
• Device Sequence Number: 16921532
• Product Code: HAW
• UDI-Device Identifier: 00613994258984
• UDI-Public: 00613994258984
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2019

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: 9732355
• Device Catalogue Number: 9732355
• Device Lot Number: 160616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 08/08/2019; 08/23/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 08/22/2019; 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1