BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL TITANIUM PROSTHESIS

    MDR report key: 3973438 · Received August 1, 2014

    Report

    Report Number
    1045254-2014-00161
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 9, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETA
    PMA / PMN Number
    K002897
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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).

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451167 UNIVERSAL TITANIUM PROSTHESIS REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL ETA MEDTRONIC XOMED INC. 1150000 0205967842

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention