MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) UNIVERSAL DRILL GUIDE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	960-521
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.No parts were returned to the manufacturer for analysis.Manufacturer date is not available.Issue occurred at (b)(6) hospital.
Event or Problem Description
Medtronic received information regarding a navigation system.It was reported that the universal drill guide had ¿come apart¿.There was no patient present when this issue was identified.
Additional Manufacturer Narrative
Manufacture date provided.

• Brand Name: UNIVERSAL DRILL GUIDE
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7895916
• Report Number: 1723170-2018-04894
• Device Sequence Number: 19220313
• Product Code: HAW
• UDI-Device Identifier: 00673978089904
• UDI-Public: 00673978089904
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K974161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2018

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 Catalogue Number: 960-521
• Device Lot Number: 170327
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/14/2018
• Supplement Date Received by Manufacturer: 09/20/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1