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 Consequences Or Impact To Patient (2199)
Date of Event	06/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device lot number, or serial number, unavailable.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.No parts have been received by the manufacturer for evaluation.Part not returned for analysis.
Event or Problem Description
A medtronic representative reported that, while in a spinal fusion, the suretrak clamp being used was deformed.The deformation was reported to be widened.The site elected to use a separate clamp to complete the procedure.There was no reported delay to the procedure due to this issue.There was no impact on patient outcome.No additional information was provided.
Additional Manufacturer Narrative
Additional information: device lot number and device manufacture date provided.
Additional Manufacturer Narrative
Device evaluation: the suspect clamp was returned to the manufacturer for evaluation and the issue was confirmed.The threads on the tip of the adjustment screw were stripped and the internal threads on the clamp arm had debris, which caused a fit issue with the mating screw.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, 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: 6691565
• Report Number: 1723170-2017-02814
• Device Sequence Number: 43529
• Product Code: OLO
• UDI-Device Identifier: 00721902467738
• UDI-Public: 00721902467738
• 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,Followup
• Report Date (Section B): 03/08/2018

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
• Device Lot Number: 150908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2018
• Initial Date Received by Manufacturer: 06/08/2017
• Supplement Date Received by Manufacturer: 06/16/2017; 02/27/2018
• Initial Report FDA Received Date: 07/06/2017
• Supplement Report FDA Received Date: 08/08/2017; 03/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1