BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR

    MDR report key: 3811301 · Received October 11, 2013

    Report

    Report Number
    1045834-2013-13327
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Date of Event
    October 26, 2012
    Report Date
    October 30, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    K965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE DEVICE WAS EVALUATED AND THE REPORTED CONDITION OF "HOLE IN HOSE" WAS CONFIRMED. DURING THE PRE-REPAIR DIAGNOSTIC ASSESSMENT THE DEVICE WAS FOUND TO HAVE "A HOLE IN THE HOSE". THE DEVICE WAS THEREFORE REPAIRED, AND PASSED ALL POST-REPAIR ACCEPTANCE CRITERIA. IF ADD'L INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM USA, STATING THAT THE DEVICE HAS A "HOLE IN THE HOSE." IT IS KNOWN THAT THE EVENT OCCURRED DURING SURGERY. IT IS ALSO KNOWN THAT THERE WAS NO PT OR USER INJURY OR MEDICAL INTERVENTION. NO ADD'L INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524021 XMAX MOTOR DRILL, SURGICAL, ENT (PNEUMATIC) - HANDPIECE ERL DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1