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

Model Number	9733066
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight: patient weight was not available.Initial reporter also sent report to fda: a medwatch report for this event was submitted to the fda by a site representative.Report number: mw5084663.Device evaluated by mfr: no parts have been received by the manufacturer for analysis.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 a cranial biopsy procedure.It was reported that one of the three 1.6mm x 8mm screws from the biopsy kit was being removed from the patient, and while doing so the surgeon noted that the head of the screw sheared off.The surgeon decided to leave the stem of the screw in the patient¿s skull and covered it with the burr-hole cover as they intended to do so.There was no delay to the case.It was noted that the surgeon describes using the device as routine.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
There was no intervention to remove the screw.Patient weight is not available.

• Brand Name: INTERNAL, TRAJECTORY GUIDE KIT
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8467016
• Report Number: 1723170-2019-01442
• Device Sequence Number: 198676
• Product Code: HAW
• UDI-Device Identifier: 00643169702929
• UDI-Public: 00643169702929
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/23/2021
• Device Model Number: 9733066
• Device Catalogue Number: 9733066
• Device Lot Number: 066223518
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 11/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR