BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR

    MDR report key: 3770297 · Received September 26, 2013

    Report

    Report Number
    1045834-2013-13811
    Event Type
    Malfunction
    Date Received
    September 26, 2013
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    K965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT REF: (B)(4) WAS ERRONEOUSLY SUBMITTED UNDER THE INCORRECT MFR 1045834-2013-13810. THE DEVICE WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE DEVICE WAS EVALUATED AND THE REPORTED CONDITION OF THE "VIBRATION AND CHATTERING" COULD NOT BE CONFIRMED. HOWEVER, DURING SERVICE AND REPAIR, THE DEVICE FAILURES WERE FOUND BUT WERE NOT RELATED TO THE REPORTED EVENT. IF ADDITIONAL INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE WAS VIBRATING AND CHATTERING. THE DEVICE WAS NOT BEING USED DURING SURGERY. IT IS UNKNOWN IF INJURY OR MEDICAL INTERVENTION WERE REPORTED. THE DATE OF THE EVENT IS UNK. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488819 XMAX MOTOR PNEUMATIC SURGICAL DRILL ERL DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1