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	12/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number was not available on the date of filing.The biopsy trajectory guide kit was returned to the manufacturer for analysis.Analysis found a mechanical failure; the returned guide stem would not seat into the base.This issue was documented in a medtronic navigation hardware anomaly tracking database.Manufacture date was not available on the date of filing.Please reference mdr 1723170-2019-00325.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system.It was reported that intra/peri-operatively during a cranial biopsy procedure, the navigus biopsy kit guide stem would not lock into the straight external base.The site opened another kit and the issue reoccurred.The site used the angled base to complete the procedure.There was no delay to the procedure.There was no reported impact on patient outcome.

• 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: 8262376
• Report Number: 1723170-2019-00326
• Device Sequence Number: 1259743
• Product Code: HAW
• UDI-Device Identifier: 00643169702912
• UDI-Public: 00643169702912
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 01/18/2019

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: 9733065
• Device Catalogue Number: 9733065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2018
• Initial Report FDA Received Date: 01/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 106