BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR

    MDR report key: 4162176 · Received October 10, 2014

    Report

    Report Number
    1045834-2014-13611
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Report Date
    April 16, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    PK131053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PRE-REPAIR ASSESSMENT PERFORMED BY TECHNICIAN, INVESTIGATION REVEALED THE DEVICE LOCKING MECHANISM WAS FAULTY DUE TO IMPROPER HANDLING. THE DEVICE WAS REPAIRED AND RETURNED TO CUSTOMER ON (B)(6) 2013.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE DEVICE NO LONGER GRASPS ATTACHMENTS. THIS IS REPORT 1 OF 1 FOR #COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643733 XMAX MOTOR DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1