BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR

    MDR report key: 4170572 · Received October 14, 2014

    Report

    Report Number
    1045834-2014-14032
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Report Date
    December 3, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    PK131053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE DEVICE PIN FOR INSTALLATION FELL OUT. THIS IS REPORT 1 OF 1 FOR #COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650752 XMAX MOTOR DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1