MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC UNIVERSAL DRILL GUIDE; INSTRUMENT, STEREOTAXIC

Model Number	960-521
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Looking down the barrel of the returned drill guide, there appeared to be lines of galling causing fit issues with the mating cannulated trocar.The reported failure has been confirmed.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.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.There was no patient present.It was reported that an issue was found with the universal drill guide udg outside of surgery.It was reported that it was difficult to insert the cannulas into the opening.

• Brand Name: UNIVERSAL DRILL GUIDE
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8193165
• Report Number: 1723170-2018-06424
• Device Sequence Number: 13772881
• Product Code: HAW
• UDI-Device Identifier: 00673978089904
• UDI-Public: 00673978089904
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/23/2018

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: 960-521
• Device Catalogue Number: 960-521
• Device Lot Number: 140722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2017
• Initial Report FDA Received Date: 12/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1