MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC ACC 960-535 MOUNT DOUBLE STAR ADAPTER; INSTRUMENT, STEREOTAXIC

Model Number	960-535
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site due to legal/confidential reasons.The instrument was not returned, so no analysis was conducted.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 for a cranial resection procedure.The issue occurred pre-operatively and caused no delay to the surgery.It was reported that the dual starburst attachment could not be fitted in well.The screw hole of the attachment could not be fitted in well.The surgery was completed with navigation/imaging system and back up products.There was no impact on patient outcome.
Additional Manufacturer Narrative
The adapter was returned to the manufacturer and analysis was completed.Functional testing and visual/physical examination was performed and no failure was found.The returned adapter was found to be in good condition with no apparent physical damage.The attachment screw and threads were intact and it was possible to mount the adapter without issue.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACC 960-535 MOUNT DOUBLE STAR ADAPTER
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8431865
• Report Number: 1723170-2019-01196
• Device Sequence Number: 1104471
• Product Code: HAW
• UDI-Device Identifier: 00681490915939
• UDI-Public: 00681490915939
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K954276
• 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,Followup
• Report Date (Section B): 06/03/2019

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: 960-535
• Device Catalogue Number: 960-535
• Device Lot Number: 090730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 06/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1