MAUDE Adverse Event Report: MEDTRONIC XOMED INC. UNIVERSAL TITANIUM PROSTHESIS; REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL

Model Number 1150000

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2014

Event Type  Injury  

Event Description

It was reported that ¿the prosthesis got broken and the shoe dropped into the patient¿s inner ear.The doctor clamped the prosthesis very tightly, but the prosthesis got broken into two parts.The doctor spent about 20 minutes to pick up the fragments and cleaning the patient¿s ear.Then, the doctor spent an extra 40 minutes to reinstall another new prosthesis.As a result, the operation was delayed for an hour.¿ there was no patient impact.

Manufacturer Narrative

Blank fields on this report are the result of information not being provided by initial reporter.This device is used for therapeutic purposes.(b)(4).Product evaluation: when received for analysis there was evidence of biological contaminants [based off of the reactivity with hydrogen peroxide].The flex h/a was separated from the titanium bell at the adhesive joint and still attached to the shaft.The flex h/a was removed from the shaft for further analysis.The head/shaft assembly measured less than 0.11¿ [required is 0.400 reference] and the shaft was consistent with being trimmed.When compared to the assembly drawing: when viewed under magnification, there was adhesive present at the break point between the flex h/a and bell which is consistent with proper manufacturing.Note: the instructions for use indicate that the shaft may be trimmed to length with scissors therefore it is not considered a malfunction.The information indicates the device was modified and mishandled which resulted in the malfunction.Results: fracture problem.(b)(4).

• Brand Name: UNIVERSAL TITANIUM PROSTHESIS
• Type of Device: REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: michelle alford ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328197
• MDR Report Key: 3973438
• MDR Text Key: 4755882
• Report Number: 1045254-2014-00161
• Device Sequence Number: 1
• Product Code: ETA
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K002897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2020
• Device Model Number: 1150000
• Device Catalogue Number: 1150000
• Device Lot Number: 0205967842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention