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 Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.The universal drill guide (udg) was returned to the manufacturer for evaluation.Testing found that the tube for the udg was detached from the handle.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 that, while outside of a procedure, the universal drill guide (udg) was damaged.There was no patient present when this issue was identified.

• 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: 8669196
• Report Number: 1723170-2019-02949
• Device Sequence Number: 11326971
• Product Code: HAW
• UDI-Device Identifier: 00673978089904
• UDI-Public: 00673978089904
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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
• Report Date (Section B): 06/04/2019

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: 960-521
• Device Catalogue Number: 960-521
• Device Lot Number: 170327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2018
• Initial Report FDA Received Date: 06/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1