MAUDE Adverse Event Report: MEDTRONIC NAVIGAITON, INC FUSION; INSTRUMENT, STEREOTAXIC

Model Number	960-527
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been received by the manufacturer for evaluation due the fact that the instrument was discarded.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system being used in a sacroiliac and thoracolumbar procedure.It was reported that when universal drill guide (udg) was being drilled the bit tip broke off.The health care professional was able to remove the broken bit without causing patient injury.The procedure was completed with navigating using the stealth midas.The procedure was delayed less than an hour.No impact on patient outcome.

• Brand Name: FUSION
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGAITON, INC; 826 coal creek circle; lousiville CO 80027
• MDR Report Key: 8312462
• Report Number: 1723170-2019-00567
• Device Sequence Number: 16194470
• Product Code: HAW
• UDI-Device Identifier: 00673978090023
• UDI-Public: 00673978090023
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K974161
• 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): 02/06/2019

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 Model Number: 960-527
• Device Catalogue Number: 960-527
• Device Lot Number: 171003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 02/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Weight: 57