MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) BIOPSY NEEDLE KIT, PASSIVE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	9733068-G02
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Device lot number, and expiration date unavailable.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.No parts have been received by manufacturer for analysis.
Event or Problem Description
A site representative reported that, while prepping for a biopsy procedure the biopsy needle was obstructed.No further details regarding the damage, or how it occurred, were provided.The surgeon was able to continue the procedure with a different needle.The surgeon completed the procedure with the use of the navigation system.There was no patient present when this issue was identified.
Additional Manufacturer Narrative
The hardware investigation of the returned needle found that the reported event was related to a physical damage issue.The passive biopsy needle outer cannula was inspected.No obstruction was visually evident.The inner cannula was used to physically check for obstructions in the outer cannula inside diameter (id) by inserting the inner cannula into the outer cannula's entire length.The inner cannula was rotated up and down the entire length of the outer cannula.No obstruction found.The inner cannula was visually inspected and the cutting window at the tip of needle was not obstructed.Note: the inner cutting window physically cuts and removes the portion of the tumor.Compressed air was used to check the inner cannula id for physical obstructions.This inspection detected an obstruction in the inner cannula id.The physical obstruction was confirmed using a length of stainless steel safety wire inserted through the cutting window up through the inner cannula.The metal obstruction in the inner cannula was located at the inner cannula opening on the overmolded hub side.Visual inspection with enhanced lighting revealed a piece of metal lodged inside the inner cannula.The piece of wire could not be dislodged.An obstruction in the inner cannula id on the overmolded hub side does not affect the functionality of the passive biopsy needle kit.Supplier engineering was notified of these findings.The reported event was confirmed.This issue was documented in a medtronic navigation hardware anomaly tracking database.
Additional Manufacturer Narrative
Additional information: issue was discussed with supplier quality engineering anthony han.Sqe decided that since the wire location did not affect the functionality of the passive biopsy needle, returning the part for supplier evaluation was not required.

• Brand Name: BIOPSY NEEDLE KIT, PASSIVE
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6033281
• Report Number: 1723170-2016-02615
• Device Sequence Number: 10961111
• Product Code: HAW
• UDI-Device Identifier: 00643169546820
• UDI-Public: 00643169546820
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K971247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2017

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: Physician
• Device Expiration Date: 02/22/2018
• Device Catalogue Number: 9733068-G02
• Device Lot Number: 066505316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/16/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/17/2016
• Supplement Report FDA Received Date: 11/11/2016; 02/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1