MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. APT EGG QUICK CONNECT HANDLE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 960-339

Device Problems Detachment Of Device Component (1104); Device Issue (2379); Device Dislodged or Dislocated (2923)

Patient Problem No Patient Involvement (2645)

Event Date 10/14/2014

Event Type  malfunction  

Event Description

A site representative reported that the metal cap of the egg handle instrument fell off.No further details regarding the damage, or how it occurred, 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.Medtronic investigation of returned suspect device finds that as reported, the cap has been broken and separated from the handle.The cap has many impact marks.The handle is otherwise functional.The reported event was confirmed to be caused by the physical damage of the handle.Replacement device shipped to site for issue resolution.

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: APT EGG QUICK CONNECT HANDLE
• Type of Device: NEUROLOGICAL 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: 4232662
• MDR Text Key: 16560732
• Report Number: 1723170-2014-01198
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,company representative
• Reporter Occupation: Health Professional
• 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: 11/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 960-339
• Device Lot Number: 100811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2010
• 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