MAUDE Adverse Event Report: QUALITY TECH SERVICES LLC TRAJ GUIDE KIT, BIOPSY, INT; INSTRUMENT, STEREOTAXIC

Model Number	9733066
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been returned for analysis.(b)(4) reflect this.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system used during a cranial biopsy.It was reported that when removing the "navigus" base from the skull, a piece of the screw snapped off into the skull.The surgeon was able to bring in a small drill to remove it.There was no delay and no impact to the patient at the time of the event.

• Brand Name: TRAJ GUIDE KIT, BIOPSY, INT
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): QUALITY TECH SERVICES LLC; 7842 hickory flat highway; suite d; woodstock GA 30188
• MDR Report Key: 9708077
• Report Number: 3012165443-2020-00003
• Device Sequence Number: 3363654
• Product Code: HAW
• UDI-Device Identifier: 00643169702929
• UDI-Public: 00643169702929
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/13/2020

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: 10/29/2022
• Device Model Number: 9733066
• Device Catalogue Number: 9733066
• Device Lot Number: 066230219B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 86