MAUDE Adverse Event Report: QUALITY TECH SERVICES LLC N/A; INSTRUMENT, STEREOTAXIC

Model Number	9733065
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/16/2021
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 instrument used during a cranial biopsy procedure.It was reported that when site put the base for the guide kit, the surgeon put a lot of pressure on the screws when attaching the base.Used an external straight base.At the end of the procedure, he broke off one of the screws.About half the screw was left in the patient's skull. surgeon tried to grab the 1mm that was sticking out and broke that piece off also.It was estimated that only a couple mm were left.The surgeon decided to leave it because it was close to the burr hole and covered it with a burr hole cover.There was about 5 minutes delay to the procedure.Impact on patient outcome is not known at this time.

• Brand Name: N/A
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): QUALITY TECH SERVICES LLC; 7842 hickory flat highway; suite d; woodstock GA 30188
• MDR Report Key: 11694418
• Report Number: 3012165443-2021-00004
• Device Sequence Number: 3481789
• Product Code: HAW
• UDI-Device Identifier: 00643169702912
• UDI-Public: 00643169702912
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K971247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/20/2021

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: 10/19/2023
• Device Model Number: 9733065
• Device Catalogue Number: 9733065
• Device Lot Number: 066229320
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 04/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1