MAUDE Adverse Event Report: QUALITY TECH SERVICES LLC BIOPSY NEEDLE; INSTRUMENT, STEREOTAXIC

Model Number	9733068
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the representative received information that before a cranial biopsy, the screw threading on the biopsy needle kit was not operational, preventing the kit from clamping (defective depth stop would not lock).The biopsy needle was not placed into the anatomy; the nurse attempted to lock the depth stop and noticed the stop did not lock prior to the unit being introduced into the anatomy.The screw to secure depth stop on the needle was stuck and not possible to tighten the stop.They took another needle and the surgery went okay.There was no reported impact on patient outcome.
Additional Manufacturer Narrative
H3: a hardware analysis was initiated to determine the probable cause of the issue.Hardware analysis found that the needle stop was incomplete.The threaded hole for the screw had not been drilled through rendering the stop unusable.The anomaly is being tracked in the navigation tracking database.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: BIOPSY NEEDLE
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): QUALITY TECH SERVICES LLC; 7842 hickory flat highway; suite d; woodstock GA 30188
• MDR Report Key: 9261593
• Report Number: 3012165443-2019-00017
• Device Sequence Number: 3730795
• Product Code: HAW
• UDI-Device Identifier: 00643169702943
• UDI-Public: 00643169702943
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2020

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: 05/15/2021
• Device Model Number: 9733068
• Device Catalogue Number: 9733068
• Device Lot Number: 066513519C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1