MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. NAV 5.5MM TAP (CANNULATED); ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 9734239

Device Problems Partial Blockage (1065); Device Reprocessing Problem (1091); Complete Blockage (1094)

Patient Problem No Patient Involvement (2645)

Event Date 05/23/2014

Event Type  malfunction  

Event Description

A medtronic ent representative reported a guide wire became lodged in a 5.5 tap.This occurred when attempts were made to remove material from the tap cannula.There was no patient present when this issue was identified.

Manufacturer Narrative

Device lot number, or serial number, not available.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.Rma issued.Replacement 5.5 cannulated tap shipped to site (b)(4) 2014.Suspect part not returned to manufacturer for analysis.

Manufacturer Narrative

Lot # now provided.Mfg date now provided.Evaluation of suspect tap found that as reported, a guide wire has been broken off inside the tap.

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 5.5MM TAP (CANNULATED)
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 9710
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 9710
• Manufacturer Contact: kristianna bilan ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902338
• MDR Report Key: 3884987
• MDR Text Key: 4546848
• Report Number: 1723170-2014-00664
• 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
• Report Date: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Equipment Company Technician/Representative
• Device Catalogue Number: 9734239
• Device Lot Number: 100525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2010
• 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