BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS HANDPIECE

    MDR report key: 3213219 · Received July 9, 2013

    Report

    Report Number
    1045834-2013-02686
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Report Date
    June 13, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE HAS BEEN RETURNED. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE UNIT MET SPECIFICATIONS. NO FAILURES WERE OBSERVED DURING THE INSPECTION. THEREFORE, THE REPORTED CONDITION WAS NOT DUPLICATED OR CONFIRMED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "A RIP IS IN THE HOSE" OF THE HAND PIECE DEVICE. THE REPORTER WAS UNABLE TO DETERMINE THE PRECISE DATE OF THIS EVENT. THERE WAS NO INFORMATION REGARDING THE PRECISE LOCATION OF THE MALFUNCTION. THE REPORTER STATED THAT THERE WAS NO DELAY IN SURGERY; NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS ALLEGED. IT WAS UNKNOWN IF AN IDENTICAL SPARE DEVICE WAS AVAILABLE FOR USE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311975 EMAX 2 PLUS HANDPIECE MOTOR, DRILL, ELECTRIC-HANDPIECE HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1