MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) SURETRAK® II UNIVERSAL TRACKER, SMALL CLAMP; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	961-576
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.A medtronic representative reported that the site elected to replace the worn screw on the clamp.It was reported that functionality was restored to the clamp.However, this confirms that the part will not be returned to the manufacturer for evaluation.Part not returned for analysis.
Event or Problem Description
A site representative reported that, while outside of a procedure, the suretrak clamp had a screw that was partially worn.There was no patient present when this issue was identified.No additional information was provided.

• Brand Name: SURETRAK® II UNIVERSAL TRACKER, SMALL CLAMP
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6814568
• Report Number: 1723170-2017-03443
• Device Sequence Number: 1077862
• Product Code: OLO
• UDI-Device Identifier: 00721902467738
• UDI-Public: 00721902467738
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K983670
• 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): 08/23/2017

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: 961-576
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 08/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1