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

Catalog Number	9734435
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information not provided due to (b)(6) patient privacy regulations.No parts have been received by manufacturer for analysis.
Event or Problem Description
A medtronic representative reported that while in a spinal fusion the tactile awl became bent.The surgeon had the tactile awl placed in the pedicle, they tried to change directions and then after removing discovered the damage, there was no reported delay to the procedure due to this issue.There was no impact on patient outcome.
Additional Manufacturer Narrative
The suspect awl was returned to the manufacturer for evaluation.Testing found that the tip of the instrument was bent.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: 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: 6198119
• Report Number: 1723170-2016-05899
• Device Sequence Number: 18845232
• 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): 06/05/2017

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: 150915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/22/2016
• Supplement Report FDA Received Date: 06/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1