MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) NAV 4.5MM TAP (CANNULATED); ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number NONE

Device Problem Complete Blockage (1094)

Patient Problem No Patient Involvement (2645)

Event Date 05/12/2015

Event Type  malfunction  

Event Description

A medtronic representative reported a site's 4.5 tap that had bone stuck in the cannulated portion of that tap.Site sterile processing staff were unable to remove the bone using a guide wire or sonication.This instrument was part of a loner tray and replacement was requested.There was no patient present when this issue was identified.

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Return requested.Replacement tap 4.5 shipped to site (b)(4) 2015.Medtronic investigation of returned suspect tap 4.5 finds that, as reported, the tap is blocked with what appears to be bone matter.Physical damage - mechanism occluded.

Manufacturer Narrative

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.

Manufacturer Narrative

On (b)(4) 2015, it was noticed that a coding error in mdr submissions from our facility resulted in the maude database incorrectly coding the devices related to our mdr submissions from (b)(4) 2015 to (b)(4)2016.The decision to wait until the database was corrected was made after consultation with the fda as advised by a consumer safety officer with the information analysis branch, division of post market surveillance, office of surveillance and biometrics.An it solution was implemented on 16-aug-2016.This mdr was submitted to correct the coding error.There is no new information to change the patient information, event description and/or manufacturer narrative that was previously reported.

Manufacturer Narrative

Correction: on 13-oct-2015, it was noticed that a previous mdr submission contained incorrect information with regards to the common device name, product code and/or pma/510(k).This mdr is being submitted to correct this information.There is no new information to change the patient information, event description or manufacturer narrative that was previously reported.

• Brand Name: NAV 4.5MM TAP (CANNULATED)
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: kristianna bilan ; 826 coal creek circle; louisville, CO 80027 ; 7208902338
• MDR Report Key: 4827759
• MDR Text Key: 5843830
• Report Number: 1723170-2015-00672
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/11/2015,02/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NONE
• Device Catalogue Number: 9734238
• Device Lot Number: 111104
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 06/11/2015
• Distributor Facility Aware Date: 06/01/2015
• Date Manufacturer Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1