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

Catalog Number 9734298

Device Problems Complete Blockage (1094); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 12/15/2016

Event Type  malfunction  

Manufacturer Narrative

The site declined to replace the 4.5 tap and the suspect device will not be returned to manufacturer for analysis.Part not received by manufacturer.

Event Description

A site representative, materials management, reported that, their 4.5 tap had a k-wire stuck inside of it.No further details regarding the damage, or how it occurred, were provided.There was no patient present when this issue was identified.

Manufacturer Narrative

The hardware investigation of the returned tap found that the reported event was related to a physical damage issue.As reported, the tap had a guide wire broken off inside.The ends of the guide wire were visible at both ends of the tap.The cannula is completely blocked.The reported event was confirmed.This issue was documented in a medtronic navigation hardware anomaly tracking database.

Manufacturer Narrative

This device is included in the medical device field correction notification, "potential for user injury ¿ medtronic navigated cannulated taps" ((b)(6) 2015).The revised instructions for use (ifu) were also provided with the notification.

• Brand Name: 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: peter verhey ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 6248340
• MDR Text Key: 64714530
• Report Number: 1723170-2017-00142
• 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
• Reporter Occupation: Health Professional
• Remedial Action: Relabeling
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• 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: 150130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1847-2015
• Patient Sequence Number: 1