MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC TRAJECTORY GUIDE KIT, BIOPSY, EXTERNAL; INSTRUMENT, STEREOTAXIC

Model Number	9733065
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The straight base was returned to the manufacturer for analysis.Analysis found that as reported the guide stem would not fit easily into the straight base on the angled base.Analysis found that the reported event was related to a mechanical issue.Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system being used for a cranial biopsy.It was reported that intra-operatively, the surgeon was unable to get the straight base to engage with the clear guide stem.They opened a second kit of a different lot number and had the same issue.The surgeon swapped to an angled base plate with a twenty minute delay and no negative impact to the patient.The rest of the case went smoothly.

• Brand Name: TRAJECTORY GUIDE KIT, BIOPSY, EXTERNAL
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9156112
• Report Number: 1723170-2019-05110
• Device Sequence Number: 2139002
• Product Code: HAW
• UDI-Device Identifier: 00643169702912
• UDI-Public: 00643169702912
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K971247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/04/2019

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 Expiration Date: 10/22/2021
• Device Model Number: 9733065
• Device Catalogue Number: 9733065
• Device Lot Number: 066229518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 73