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

Model Number	9733068
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.The biopsy needle kit was returned to the manufacturer for evaluation.Testing found that the depth stop on the needle was not drilled through the set screw.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.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 screw on the adjustable depth collar would not tighten.The biopsy needle was replaced and the issue was resolved.There was no reported delay and no reported impact to patient outcome.

• 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: 9716598
• Report Number: 3012165443-2020-00004
• Device Sequence Number: 3270276
• Product Code: HAW
• UDI-Device Identifier: 00643169702943
• UDI-Public: 00643169702943
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/17/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 02/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1