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

Model Number 9733065

Device Problem Material Integrity Problem (2978)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/16/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): QUALITY TECH SERVICES LLC; 7842 hickory flat highway; suite d; woodstock GA 30188
• Manufacturer (Section G): QUALITY TECH SERVICES LLC; 7842 hickory flat highway; suite d; woodstock GA 30188
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11694418
• MDR Text Key: 249478387
• Report Number: 3012165443-2021-00004
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169702912
• UDI-Public: 00643169702912
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1