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

Catalog Number	960-539
Medical Device Problem Codes	Mechanical Problem (1384); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information not provided due to (b)(6) patient privacy regulations.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.No parts have been received by the manufacturer for evaluation.Part not returned for analysis.
Event or Problem Description
A medtronic representative reported that, while in a cranial biopsy, the biopsy guide could not be tightened sufficiently.It was reported that the screw would move when minimal force was applied.The site elected to complete the procedure with the biopsy guide.There was no reported delay to the procedure due to this issue.There was no impact on patient outcome.No additional information was provided.
Additional Manufacturer Narrative
Additional information: device manufacture date and lot number provided.The suspect biopsy guide was returned to the manufacturer for evaluation.Testing found that the adjustment screw was difficult to operate where tightening the screw was difficult.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.

• Brand Name: BIOPSY GUIDE
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7049827
• Report Number: 1723170-2017-04798
• Device Sequence Number: 1690809
• Product Code: HAW
• UDI-Device Identifier: 00681490991520
• UDI-Public: 00681490991520
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K954276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2017

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 Catalogue Number: 960-539
• Device Lot Number: 080202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Initial Date Received by Manufacturer: 10/25/2017
• Supplement Date Received by Manufacturer: 12/06/2017
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1