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

Catalog Number	960-521
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Device lot number not available as the site discarded the part before the lot number could be documented.No parts have been received by the manufacturer for evaluation.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.
Event or Problem Description
Medtronic received information regarding a navigation device being used outside of procedure.It was reported that the universal drill guide (udg), where you insert the drill guide, was found to be stripped.No patient was present.
Additional Manufacturer Narrative
Correction: manufacturer updated to proper value.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The device manufacture representative spoke to the facility, they believe they ended up getting the universal drill guide (udg) to work without replacing it.The facility thought they may have just had new staff using it that thought it was damaged or they may have switched out one of the ¿fighter¿ arrays from another pan they weren¿t using routinely.

• 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: 7614135
• Report Number: 1723170-2018-02856
• Device Sequence Number: 19319338
• Product Code: HAW
• UDI-Device Identifier: 00673978089904
• UDI-Public: 00673978089904
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/08/2019

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: Physician
• Device Catalogue Number: 960-521
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 09/17/2018; 09/17/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 09/20/2018; 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1