MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S7; 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	07/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 two drill bits were wobbly in the drill guide.The representative was performing a test of the drill bits to see if he could recreate the issue.It was further noted that they tested both 2.4 drill bits out of the udg trays.It was confirmed that they were bent and will need a replacement for both trays.There was a delay to the procedure of less than one hour.There was no reported impact on patient outcome.

• Brand Name: STEALTHSTATION S7
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8855822
• Report Number: 1723170-2019-04347
• Device Sequence Number: 2028624
• Product Code: HAW
• UDI-Device Identifier: 00673978090023
• UDI-Public: 00673978090023
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/02/2019

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: 140805
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 08/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 75