MAUDE Adverse Event Report: QUALITY TECH SERVICES LLC BIOPSY NEEDLE KIT, PASSIVE; 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	10/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been returned to the manufacturer for analysis.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 site had a biopsy needle whose depth stop would not fully tighten due to damage.It was noted that this was an out of box issue and that the site used a piece of sterile stripping to complete the case.There was no surgical delay and no impact on the patient outcome.

• Brand Name: BIOPSY NEEDLE KIT, PASSIVE
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): QUALITY TECH SERVICES LLC; 7842 hickory flat highway; suite d; woodstock GA 30188
• MDR Report Key: 9284950
• Report Number: 3012165443-2019-00018
• Device Sequence Number: 2352306
• Product Code: HAW
• UDI-Device Identifier: 00643169702943
• UDI-Public: 00643169702943
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/06/2019

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: 02/08/2021
• Device Model Number: 9733068
• Device Catalogue Number: 9733068
• Device Lot Number: 066503919
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 97