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 Problems Tissue Damage (2104); Injury (2348); Needle Stick/Puncture (2462)

Event Date 02/06/2014

Event Type  Injury  

Event Description

A medtronic representative reported that while a site representative was using a k-wire to clean bone out of a cannulated tap, the k-wire slipped and the wire ran through one finger and into the glove of the next finger.The site representative went to the emergency room to have the k-wire removed and received medical treatment for a possibly contaminated wire-stick.The site representative has not reported any longterm negative effects from the wire-stick.This occurred outside of a surgical procedure during instrument cleaning.

Manufacturer Narrative

(b)(4).Device lot number, or serial number, not available from the site; the specific device this event occurred with is not known.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.The specific device was not noted at the time of the event and cannot be recalled by the site representative; no parts will be returned to the manufacturer for analysis.Medtronic navigation is filing this mdr to ensure visibility to a site employee injury as a result of an event that involved a medtronic cannulated tap.

Manufacturer Narrative

Patient age and weight now provided.The site employee confirmed she has not had any infection due to the reported incident.

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: 3691014
• MDR Text Key: 4244180
• Report Number: 1723170-2014-00285
• 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?: Yes
• 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
• Initial Date Manufacturer Received: 03/20/2014
• Initial Date FDA Received: 03/20/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/19/2014; 11/10/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 79