MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 961-349 SUGITA HEADFRAME ADAPTER; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	961-349
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.It was reported by the rep that the connecting part of the frame was worn out and could no longer be used.Replacement of the frame resolved the issue.No further issues were reported.Replaced frame was not returned to manufacturer for analysis, therefore, no findings are possible.Part not returned.
Event or Problem Description
A medtronic representative reported that the head frame thread was worn and could no longer support the arm.There was no patient present when this issue was identified.
Additional Manufacturer Narrative
Additional information: lot number and device manufacture date provided.The suspect adapter was returned to the manufacturer for analysis.The adapter was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.

• Brand Name: 961-349 SUGITA HEADFRAME ADAPTER
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6575398
• Report Number: 1723170-2017-02083
• Device Sequence Number: 1169894
• Product Code: HAW
• UDI-Device Identifier: 00681490869805
• UDI-Public: 00681490869805
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K954276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2017

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: 961-349
• Device Lot Number: 150203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Initial Date Received by Manufacturer: 04/19/2017
• Supplement Date Received by Manufacturer: 08/09/2017
• Initial Report FDA Received Date: 05/18/2017
• Supplement Report FDA Received Date: 08/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1