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	07/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been received by the manufacturer for evaluation.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 during a cranial biopsy procedure.It was reported that a screw broke off upon removal of the skull-mounted base.The head of the screw broke off, leaving the bottom, threaded portion of the screw in the skull.A burrhole cover plate was placed on the skull.Upon closure, the piece of the screw remains in the patient skull.There was no delay to the procedure.There was no reported impact to patient outcome; the patient was doing well and required no further action or intervention.It was suspected that the screw was overtightened/torqued.

• 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: 10422359
• Report Number: 1723170-2020-02205
• Device Sequence Number: 2816333
• Product Code: HAW
• UDI-Device Identifier: 00643169702912
• UDI-Public: 00643169702912
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 08/18/2020

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: 05/01/2021
• Device Model Number: 9733065
• Device Catalogue Number: 9733065
• Device Lot Number: 066212118
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 90