BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 3173358 · Received June 17, 2013

    Report

    Report Number
    1045834-2013-02475
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 28, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE HAS BEEN RETURNED. RELIABILITY ENGINEERING EVALUATED THE DEVICE. THE REPORTED CONDITION COULD NOT BE 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 THE HAND PIECE DEVICE "WOULD NOT RUN". IT WAS UNKNOWN TO THE REPORTER IF THE DEVICE WAS BEING USED IN A SURGICAL PROCEDURE OR IF THERE WERE ANY DELAYS. IT WAS UNKNOWN IF THERE WAS PATIENT HARM, ADVERSE OUTCOME OR INJURY ALLEGED. THE DATE OF THE EVENT IS UNKNOWN; HOWEVER, IT WAS STATED THAT IT HAD OCCURRED IN 2013. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED IF FURTHER INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273134 EMAX 2 PLUS MOTOR MOTOR, DRILL, ELECTRIC - HAND PIECE HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1