BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILLCHUCK DRILLING SPEED W/KEY F/TRS CL

    MDR report key: 3192608 · Received June 27, 2013

    Report

    Report Number
    2520274-2013-03836
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 31, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2013, GREASE WAS LEAKING FROM THE DRILL CHUCK ATTACHMENT WHEN THE SURGEON USED THE TRAUMA RICON SYSTEM(TRS) AFTER STERILIZATION AND DRYING. THE HOSPITAL STAFF STERILIZED THIS ATTACHMENT ACCORDING TO SURGICAL GUILD. THE SURGEON STOPPED USE OF THE DEVICE OUT OF CONCERN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294565 DRILLCHUCK DRILLING SPEED W/KEY F/TRS CL HWE SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR