BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSTHESIS - UNIVERSAL TITANIUM PROSTHESIS

    MDR report key: 5382956 · Received January 21, 2016

    Report

    Report Number
    1045254-2016-00017
    Event Type
    Malfunction
    Date Received
    January 21, 2016
    Date of Event
    December 24, 2015
    Report Date
    December 28, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETA
    PMA / PMN Number
    K002897
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE DEVICE WAS RETURNED AND EVALUATED. CONDITION UPON RECEIPT: 1 UN-SEALED SAMPLE, PART NUMBER 1150001, FROM LOT NUMBER 0206940323 RECEIVED; THERE WAS EVIDENCE OF BIOLOGICAL CONTAMINANTS [BASED OFF OF THE REACTIVITY WITH HYDROGEN PEROXIDE]. EQUIPMENT USED: MICROSCOPE (ZEISS STEMI 2000C BETWEEN 0, 65 TO 5, 0 MAGNIFICATION SETTINGS), CALIPERS (ASSET 1080-J). EVALUATION: WHEN COMPARED TO THE ASSEMBLY DRAWING: VISUALLY, THE FLEX H/A WAS BROKE OFF OF THE TITANIUM BELL WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT. THERE WAS A RESIDUE CONSISTENT WITH ADHESIVE AT THE JUNCTURE BETWEEN THE FLEX H/A AND TITANIUM BELL WHICH INDICATES IT WAS MANUFACTURED PER THE DRAWING. WHEN VIEWED UNDER MAGNIFICATION, THE HEAD / SHAFT ASSEMBLY WAS CONSISTENT WITH BEING MODIFIED / TRIMMED. THE HEAD SHAFT ASSEMBLY MEASURED 0.156¿ AND THE CONFIGURATION OF THE END WAS CONSISTENT WITH BEING CUT. THE TITANIUM BELL LEGS WERE BENT INWARD AND THE H/A HAD SCRATCHES WHICH INDICATES MISHANDLING. THE COMPLAINT WAS CONFIRMED FOR THE ALLEGED MALFUNCTION [THE SHOE PART BROKE]. BASED ON THE PRODUCT ANALYSIS FINDINGS THE MOST LIKELY CAUSE OF THE EVENT IS CONSISTENT WITH OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE SHOE PART OF THE PROSTHESIS GOT BROKEN DURING OPERATION. THE DOCTOR USED ANOTHER NEW PROSTHESIS TO COMPLETE TO SURGERY." THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43243 PROSTHESIS - UNIVERSAL TITANIUM PROSTHESIS REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL ETA MEDTRONIC XOMED INC. 1150001 0206940323

    Patients

    Seq Age Sex Outcome Treatment
    1