MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CLAMP, THORACIC, RADIOLUCENT; INSTRUMENT, STEREOTAXIC

Model Number	9733148
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been returned to the manufacturer for analysis.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device outside of a procedure.It was reported that the site had a broken instrument that needed replacement.The thoracic clamp's screw thread was defragmented.There was no patient involvement.
Additional Manufacturer Narrative
The clamp, 9733148, thoracic, radiolucent (lot# 150327) was returned for analysis.Through functional testing and visual/physical examination analysis found physical damage.The adjustment screw of the returned clamp had debris in the threads causing difficulty in the travel of the screw.The clamp was otherwise functional.This issue was documented in a medtronic navigation hardware anomaly tracking database.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CLAMP, THORACIC, RADIOLUCENT
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8467958
• Report Number: 1723170-2019-01448
• Device Sequence Number: 16191079
• Product Code: HAW
• UDI-Device Identifier: 00613994201263
• UDI-Public: 00613994201263
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2019

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: 9733148
• Device Catalogue Number: 9733148
• Device Lot Number: 150327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Initial Date Received by Manufacturer: 03/01/2019
• Supplement Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 03/30/2019
• Supplement Report FDA Received Date: 08/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1