MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. NAVLOCK; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9734678
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A manufacturer representative went to the site to test the navigation system.On-site visual and functional testing was completed on the system.It was reported that the awl sharp blocked in the navlock during surgery.The issue was resolved with the replacement of the instrument.The instrument was returned to the manufacturer for evaluation.After visual and functional testing, it was confirmed that the returned instrument had impact marks at the back end causing fit issues with the mating tracker.Physical damage to the instrument was confirmed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation instrument post-operatively of a sacroiliac and thoracolumbar procedure.It was reported that the awl sharp blocked the navlock after surgery.There was no delay in surgery and no impact to the patient.

• Brand Name: NAVLOCK
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7964721
• Report Number: 1723170-2018-05135
• Device Sequence Number: 168744
• Product Code: OLO
• UDI-Device Identifier: 00613994870049
• UDI-Public: 00613994870049
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2018

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: Health Professional
• Device Model Number: 9734678
• Device Catalogue Number: 9734678
• Device Lot Number: 160429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 10/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 64