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	09/28/2017
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 manufacturer for evaluation.Part not returned for evaluation.
Event or Problem Description
A site representative reported that while outside of procedure, the screw of thoracic clamp was stripped.There was no patient present at the time of the issue.
Additional Manufacturer Narrative
Correction: the suspect clamp was returned to the manufacturer for evaluation.It was reported that the adjustment screw thread were damaged but did not affect the functionality of the unit.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.

• 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: 6980194
• Report Number: 1723170-2017-04326
• Device Sequence Number: 118253
• 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: company representative,health
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2018

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: 110504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Initial Date Received by Manufacturer: 09/28/2017
• Supplement Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 10/26/2017
• Supplement Report FDA Received Date: 04/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1