MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X PROSTHETIC HEART VALVE; MECHANICAL HEART VALVE

Model Number	ONXM
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/06/2015
Type of Reportable Event	Malfunction
Event or Problem Description
As per the request submitted by fda medwatch program, this report is being resubmitted as report number 1649833-2016--70017-1.This report was initially submitted as follow-up report 1649833-2016-70030 - 1, march 30, 2016.Description from medwatch report as follows: this is a follow-up report to the original mor no.1649833-2015-70030.Event occurred in usa.Original report stated leaflet broke while rotating the valve.The valve has been returned and investigated and it was found that the leaflet had been pushed out of its socket while attempting rotation, and in the process the housing coating was fractured in a number of areas.The conclusion is that the damage resulted from using a rotator that is smaller than the valve size, allowing rotational forces to be applied to the leaflets.The correct size rotator applies rotational forces safely to strong features on the housing interior.In brief, it is summarized as "iatrogenic damage".The ifu clearly warns against using undersized rotators as it can result in damage.This was not a structural valve dysfunction caused by latent defect in the valve.

• Brand Name: ON-X PROSTHETIC HEART VALVE
• Common Device Name: MECHANICAL HEART VALVE
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln; bldg b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln; bldg b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1300 e. anderson ln; bldg b; austin, TX 78752 ; 7704193355
• MDR Report Key: 5536466
• Report Number: 1649833-2016-70017
• Device Sequence Number: 17058639
• Product Code: DYE
• UDI-Device Identifier: 00851788001280
• UDI-Public: 00851788001280
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/30/2019
• Device Model Number: ONXM
• Device Catalogue Number: ONXM-27/29
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2015
• Supplement Date Received by Manufacturer: 11/09/2015
• Initial Report FDA Received Date: 03/30/2016
• Supplement Report FDA Received Date: 03/30/2016
• Date Device Manufactured: 10/30/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown