BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAUTREY ARCH BAR, 15CM

    MDR report key: 3388261 · Received October 4, 2013

    Report

    Report Number
    0008010177-2013-00251
    Event Type
    Malfunction
    Date Received
    October 4, 2013
    Date of Event
    September 10, 2013
    Report Date
    September 11, 2013
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    EHO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD BE CONFIRMED. VISUAL INSPECTION REVEALED THAT THE EDGES OF THE CURRENT ARCH BARS ARE VERY SHARP. HOWEVER, WITHIN FUNCTIONAL INSPECTION THE REPORTED EVENT COULD NOT BE REPRODUCED. ALSO A COMPARISON WITH THE CURRENT DRAWING HAS SHOWN THAT THE PRODUCTS MEET THE SPECIFICATION. TO ADDRESS THE CUSTOMER CONCERNS A CHANGE REQUEST WAS INITIATED ON 2014-MAR-10 TO REDESIGN THE ARCH BAR IN A WAY IT GETS SMOOTHER. AS A PART OF THE REDESIGN THE EDGES WILL BE NEW DEFINED (ROUNDED OFF) AND THE PEGS MORE CURVED. THE CHANGE REQUEST IS STILL ONGOING.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED THAT THE ARCH BAR HAS EDGES. IT PULLS OR TEARS GUMS. THE RAIL IS VERY EDGY AND IT IS FEARED THAT IT CAN HURT THE PATIENT. THE CUSTOMER HAD TO TOP THE ITEMS OFF, REGRIND THEM AND BEND THEM BEFORE USE WHICH CAUSED A DELAY OF 30 MINUTES.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED THAT THE ARCH BAR HAS EDGES. IT PULLS OR TEARS GUMS. THE RAIL IS VERY EDGY AND IT IS FEARED THAT IT CAN HURT THE PATIENT. THE CUSTOMER HAD TO TOP THE ITEMS OFF, REGRIND THEM AND BEND THEM BEFORE USE WHICH CAUSED A DELAY OF 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504234 DAUTREY ARCH BAR, 15CM INSTRUMENT EHO STRYKER LEIBINGER FREIBURG 6000008879

    Patients

    Seq Age Sex Outcome Treatment
    1