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

Catalog Number	961-578
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Rma issued, replacement device shipped to site for issue resolution.No parts have been received by manufacturer for analysis.Not returned to manufacturer.
Event or Problem Description
A medtronic representative reported that during a spinal fusion case, the site discovered that the screw thread of the suretrak clamp is stripped.There was no delay as a result of this issue, and procedure was successfully completed with no adverse effect on patient outcome.
Additional Manufacturer Narrative
Investigation of returned suspect suretrak clamp finds that the adjustment screw has been cross threaded into the clamp and is no longer functional.The reported issue was confirmed to be caused by a mechanical failure of the screw threads.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: SURETRAK II UNIVERSAL TRACKER, MEDIUM CLAMP
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6030002
• Report Number: 1723170-2016-02551
• Device Sequence Number: 13563323
• Product Code: OLO
• UDI-Device Identifier: 00721902467714
• UDI-Public: 00721902467714
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K983670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2016

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 Catalogue Number: 961-578
• Device Lot Number: 160201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/14/2016
• Supplement Report FDA Received Date: 11/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1