MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) TACTILE AWL; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	9734435
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information not provided due to canadian patient privacy regulations.No parts have been received by the manufacturer for evaluation.
Event or Problem Description
A medtronic representative reported that, while in a spinal fusion, the tactile awl could not remain in the tera tracker being used.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no impact on patient outcome.No additional information was provided.
Additional Manufacturer Narrative
The suspect awl was returned to the manufacturer for analysis.The awl was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.

• Brand Name: TACTILE AWL
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6658494
• Report Number: 1723170-2017-02594
• Device Sequence Number: 19120134
• Product Code: OLO
• UDI-Device Identifier: 00613994759610
• UDI-Public: 00613994759610
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K124004
• 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): 10/16/2017

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: Physician
• Device Catalogue Number: 9734435
• Device Lot Number: 160322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Initial Date Received by Manufacturer: 05/25/2017
• Supplement Date Received by Manufacturer: 09/20/2017
• Initial Report FDA Received Date: 06/21/2017
• Supplement Report FDA Received Date: 10/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1