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	05/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information not provided due to (b)(6) patient privacy regulations.No parts were replaced.No parts were received by manufacturer for evaluation.
Event or Problem Description
A medtronic representative reported that during a spinal fusion procedure the tip of the instrument was found bent when the instrument was removed from pedicle during a posterior instrumented fusion.There was no impact on patient.Delay to surgery was less than 1 hour.
Additional Manufacturer Narrative
The tactile instrument was returned to the manufacturer for analysis.Analysis found that the tip of the tactile probe was bent.Analysis found that the reported event was related to a physical damage issue.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: 6670201
• Report Number: 1723170-2017-02676
• Device Sequence Number: 11193408
• 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): 05/25/2018

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: 9734435
• Device Lot Number: 160112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Initial Date Received by Manufacturer: 05/31/2017
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 06/27/2017
• Supplement Report FDA Received Date: 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1