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

Catalog Number 9734298

Device Problems Complete Blockage (1094); Occlusion Within Device (1423)

Patient Problem No Patient Involvement (2645)

Event Date 10/15/2014

Event Type  malfunction  

Manufacturer Narrative

Evaluation of suspect tap as follows: as reported, a guide wire has been broken off inside the tap.Also, the tip of the instrument has been blunted and slightly fluted out.Otherwise, the tap is in good condition and inserts and releases easily from a navlock.

Event Description

A medtronic representative received a report from a site that when attempting to clean their 4.5mm cannulated tap, a metal wire became lodged in the cannula.An obstruction, and wire, are stuck in the tap.No further details were provided.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 4.5 tap shipped to site (b)(4) 2014.No parts have been returned to manufacturer for analysis.

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: 4.5MM 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: 4243376
• MDR Text Key: 19013939
• Report Number: 1723170-2014-01210
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9734298
• Device Lot Number: 130722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2014
• Initial Date FDA Received: 11/11/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/14/2015; 11/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2013
• 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