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

Model Number 9734678

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from site.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 Description

Medtronic received information regarding a navigation instrument during 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
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8196950
• MDR Text Key: 131426448
• Report Number: 1723170-2018-06432
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00613994870049
• UDI-Public: 00613994870049
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K124004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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: 01/26/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1