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 Patient Involvement (2645)
Date of Event	11/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Return requested.Replacement suretrak2 medium clamp shipped to site 12/02/2016.No parts have been received by manufacturer for analysis.
Event or Problem Description
A site purchasing representative reported that their suretrak2 medium clamp had a damaged screw.No further details regarding the damage, or how it occurred, were provided.There was no patient present when this issue was identified.
Additional Manufacturer Narrative
Investigation of returned suspect clamp finds that the reported problem was confirmed.The female hex part of the screw was found to be striped out.The reported issue was confirmed to be caused my physical damage to the screw head.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: 6172061
• Report Number: 1723170-2016-05772
• Device Sequence Number: 673678
• Product Code: OLO
• UDI-Device Identifier: 00721902467714
• UDI-Public: 00721902467714
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K983670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2017

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: Health Professional
• Device Catalogue Number: 961-578
• Device Lot Number: 141014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2016
• Supplement Report FDA Received Date: 01/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1