MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC MOUNT ASSY 9733825 REPEATABLE - IOI; INSTRUMENT, STEREOTAXIC

Model Number	9733825
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instrument was returned for analysis.Functional testing determined that the instrument was damaged causing the reported issue.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 for an optical tumor resection procedure.It was reported that the site was having issues with the reference frame not properly mounting with in the mount which was causing the frame to be very loose.A tech noticed the issue during procedure.They noted that the reference frame appeared to be loose in its mount.The surgeon stated that navigation appeared accurate and proceeded with the surgery using navigation.After the surgery the threads seemed to have back out of the mount such that it was slightly elevated and prevent the frame from fully seating.There was a less than 5 minute delay and no reported impact to patient outcome.

• Brand Name: MOUNT ASSY 9733825 REPEATABLE - IOI
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9459125
• Report Number: 1723170-2019-05989
• Device Sequence Number: 3104026
• Product Code: HAW
• UDI-Device Identifier: 00763000053468
• UDI-Public: 00763000053468
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2019

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: No Information
• Device Model Number: 9733825
• Device Catalogue Number: 9733825
• Device Lot Number: 190124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 12/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 12 YR
• Patient Weight: 51