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	01/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.The suspect clamp was returned to the manufacturer for evaluation.Visual inspection found that the clamp face was slightly bent.Functional testing found that the retainer ring was stretched, allowing play in the clamp when tightened.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.
Event or Problem Description
A site representative reported that, while outside of a procedure, an instrument was damaged.There was no patient present when this issue was identified.No additional information was provided.

• 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: 7197789
• Report Number: 1723170-2018-00255
• Device Sequence Number: 16632216
• Product Code: HAW
• UDI-Device Identifier: 00613994201263
• UDI-Public: 00613994201263
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K990214
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/16/2018

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: 120529
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2018
• Initial Report FDA Received Date: 01/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1