MAUDE Adverse Event Report: MDT SURGICAL NAVIGATION TECH 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	02/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.The clamp thoracic radiolucent was returned to the manufacturer for analysis.Analysis found that the threads of the adjustment screw was worn down in the middle of the travel, but it was still functional.The retainer ring on the tip of the screw was also stretched allowing some play in the movement of the clamp face.Analysis found that the reported event was related to a physical issue.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device.It was reported that the screw of a spine clamp was worn.This was observed outside of a surgical procedure.No patient involved.

• Brand Name: CLAMP, THORACIC, RADIOLUCENT
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MDT SURGICAL NAVIGATION TECH INC; louisville
• MDR Report Key: 8310648
• Report Number: 1723170-2019-00560
• Device Sequence Number: 13987747
• Product Code: HAW
• UDI-Device Identifier: 00613994201263
• UDI-Public: 00613994201263
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K990214
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/06/2019

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 Expiration Date: 10/31/2014
• Device Model Number: 9733148
• Device Catalogue Number: 9733148
• Device Lot Number: 120426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 02/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1