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 Known Impact Or Consequence To Patient (2692)
Date of Event	08/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biopsy needle was returned to the manufacture for evaluation.After visual/physical examination the reported issue was confirmed.As reported, the drill stop has not been drilled through so the screw cannot make contact with the needle.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding navigation devices being used for a cranial biopsy procedure.It was reported that the stop for the biopsy needles didn¿t have threads all the way down which was preventing the surgeon from locking the stop.It was noted that the issue had occurred on two biopsy needles from the same lot.It was noted that the surgeon was able to make it work and that there was a surgical delay of 5 minutes.There was no impact on 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: 8925787
• Report Number: 3012165443-2019-00012
• Device Sequence Number: 1948870
• Product Code: HAW
• UDI-Device Identifier: 00643169702943
• UDI-Public: 00643169702943
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K971247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/23/2019

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: 05/03/2021
• Device Model Number: 9733068
• Device Catalogue Number: 9733068
• Device Lot Number: 066512319A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 91