MAUDE Adverse Event Report: QUALITY TECH SERVICES LLC CRANIAL BIOPSY NEEDLE KIT; 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	09/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.No parts have been received by the manufacturer for evaluation.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 pre-operatively of a cranial biopsy procedure.It was reported that the grub screw on the blue washer for locking the needle biopsy distance was faulty in three different needles in the same batch.The inner threads were not perforated to allow the screw to come through.The site was able to use another needle from a different batch number to complete the procedure.There was a less than 1-hour delay to the procedure and no impact on patient outcome.

• Brand Name: CRANIAL BIOPSY NEEDLE KIT
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): QUALITY TECH SERVICES LLC; 7842 hickory flat highway; suite d; woodstock GA 30188
• MDR Report Key: 9287553
• Report Number: 3012165443-2019-00020
• Device Sequence Number: 129261
• Product Code: HAW
• UDI-Device Identifier: 00643169702943
• UDI-Public: 00643169702943
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K971247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• 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: 05/15/2021
• Device Model Number: 9733068
• Device Catalogue Number: 9733068
• Device Lot Number: 066513519C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2019
• 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