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

Catalog Number 9734238

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

Patient Problem No Patient Involvement (2645)

Event Date 04/09/2015

Event Type  malfunction  

Event Description

A medtronic representative received a report from a site sterile processing department (spd) manager alleging they cannot clean all the bone out of their cannulated taps.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.Device lot number not available.Device manufacturing date is dependent on lot number, therefore, unavailable.The site did not request replacements, nor will they return their nav 4.5mm cannulated taps to manufacturer for analysis.Mechanical/instrument engineering analysis reports "the cannulated spine taps are intended to be used in mis (minimally-invasive surgery) procedures using a guidewire.If cannulated taps are used without a guide wire, bone will accumulate in the cannula and the device will be considered at the end of its useful life.The cannulated tap should be disposed according to national regulations." no further issues have been 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.; 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: 4756576
• MDR Text Key: 5887389
• Report Number: 1723170-2015-00568
• 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
• Report Date: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9734238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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