MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC AXIEM¿ CRANIAL NON-INVASIVE SHUNT KIT; INSTRUMENT, STEREOTAXIC

Model Number	9733605
Medical Device Problem Code	Device Unsafe to Use in Environment (2918)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/06/2019
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.It was reported that there was a hair in the sterile package of the axiem shunt kit.This was found before it was opened up.A new one was pulled and used without incident.There was no patient involvement and no delay of the case.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The component was returned for analysis.Visual/physical examination of the returned shunt kit confirmed the reported issue.The returned kit had a hair inside the sealed package.This issue has been documented in a hardware anomaly tracking database.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AXIEM¿ CRANIAL NON-INVASIVE SHUNT KIT
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8603627
• Report Number: 1723170-2019-02301
• Device Sequence Number: 3030705
• Product Code: HAW
• UDI-Device Identifier: 00643169425019
• UDI-Public: 00643169425019
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K141833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/23/2019

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: 08/20/2020
• Device Model Number: 9733605
• Device Catalogue Number: 9733605
• Device Lot Number: 180821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 05/14/2019; 10/09/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 06/10/2019; 10/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1