MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC PASSIVE BIOPSY NAVIGUS SET; INSTRUMENT, STEREOTAXIC

Model Number	9733065
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Tissue Damage (2104); Iatrogenic Source (2498)
Date of Event	11/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was discarded by the site therefore no analysis can be performed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system.It was reported that intra/peri-operatively during a cranial biopsy procedure, the site was having difficulties removing the screws from the skull mounted base.Two of the screws broke off into the patients skull and had to be drilled out.There was a delay to the procedure of 5 minutes.The site reported minimal impact to patient.Entire disposable biopsy kit disposed of by the site.

• Brand Name: PASSIVE BIOPSY NAVIGUS SET
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8109760
• Report Number: 1723170-2018-05889
• Device Sequence Number: 16577384
• Product Code: HAW
• UDI-Device Identifier: 00763000215620
• UDI-Public: 00763000215620
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2021
• Device Model Number: 9733065
• Device Catalogue Number: 9733065
• Device Lot Number: 066212118A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 11/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Weight: 68