MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CLAMP, THORACIC, RADIOLUCENT; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	9733148
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.No parts have been received by the manufacturer for evaluation.Part not returned for evaluation.
Event or Problem Description
A site representative reported that while outside of procedure, the screw of the reference clamp was worn.There was no patient present at the time of the issue.
Additional Manufacturer Narrative
The clamp case part was not returned for analysis.
Event or Problem Description
Medtronic received information regarding a navigation device being used outside of procedure, with no patient present.It was reported that the screw of the reference clamp was worn and needed a replacement.

• Brand Name: CLAMP, THORACIC, RADIOLUCENT
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7280890
• Report Number: 1723170-2018-00760
• Device Sequence Number: 1212579
• Product Code: HAW
• UDI-Device Identifier: 00613994201263
• UDI-Public: 00613994201263
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• PMA/510(K) Number: K990214
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2018

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: Physician
• Device Catalogue Number: 9733148
• Device Lot Number: 121214
• Initial Date Received by Manufacturer: 01/25/2018
• Supplement Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 02/19/2018
• Supplement Report FDA Received Date: 08/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1