BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 3252956 · Received July 29, 2013

    Report

    Report Number
    1045834-2013-03720
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    May 3, 2011
    Report Date
    May 5, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE DEVICE WAS EVALUATED AND THE REPORTED CONDITION OF "LOCKING MECHANISM ISN'T WORKING" WAS NOT CONFIRMED. RELIABILITY ENGINEERING DETERMINED THAT THE "SLEEVE WAS STIFF AND DID NOT OPERATE SMOOTHLY", HOWEVER, THE LOCKING MECHANISM WAS FOUND TO FUNCTION. IT WAS CONCLUDED THAT THE MOST LIKELY ASSIGNABLE CAUSE WAS "IMPROPER OR INEFFECTIVE CLEANING OF THE EQUIPMENT". THE DEVICE WAS REPAIRED AND PASSED FINAL ACCEPTANCE CRITERIA. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE (B)(6) STATING THAT THE "LOCKING MECHANISM ISN'T WORKING" ON THE DEVICE. THE DEVICE WAS NOT BEING USED DURING SURGERY. IT IS UNKNOWN IF INJURY OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352125 EMAX 2 PLUS MOTOR MOTOR, DRILL, ELECTRIC - HANDPEICE HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1