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	08/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Return requested for suspect suretrak2 medium clamp.No parts have been received by manufacturer for analysis.No further issues have been reported.
Event or Problem Description
A medtronic representative reported that, while in a posterior spinal fusion procedure, the screw thread on the mount of the site's suretrak clamp was broken.No further details regarding the damage, or how it occurred, were provided.The surgeon opted to continue and completed the procedure with the use of the navigation system.There was no delay of therapy.There was no impact on patient outcome.
Additional Manufacturer Narrative
Investigation of returned suspect clamp was unable to replicate the reported issue.The adjustment screw thread is slightly damaged causing slight resistance when tightening the clamp, but the clamp is otherwise fully functional.

• 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: 5982076
• Report Number: 1723170-2016-02374
• Device Sequence Number: 16383264
• 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,consum
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2016

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: Physician
• 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: 08/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/27/2016
• Supplement Report FDA Received Date: 11/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1