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

Catalog Number	961578
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/03/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Return requested.Replacement suretrak2 clamp medium shipped to site 11/04/2016.Medtronic investigation of returned suspect suretrak2 clamp medium finds that clamp adjustment screw head is somewhat rounded out causing difficulty setting the clamp.The clamp is otherwise functional.Physical damage - rounded head/damaged screw hardware investigation was completed.This issue was found related to a hardware issue and was documented in a medtronic hardware anomaly tracking database.
Event or Problem Description
A site purchasing department representative reported that their suretrak2 medium clamp was damaged.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
The device was returned for analysis and not repaired and returned.

• Brand Name: SURETRAK II UNIVERSAL TRACKER, MEDIUM CLAMP
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6141240
• Report Number: 1723170-2016-05605
• Device Sequence Number: 18888097
• Product Code: HAW
• UDI-Device Identifier: 00721902672279
• UDI-Public: 00721902672279
• 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): 12/21/2016

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: 961578
• Device Lot Number: 160201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/03/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/02/2016
• Supplement Report FDA Received Date: 12/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1