BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR

    MDR report key: 3181544 · Received June 21, 2013

    Report

    Report Number
    1045834-2013-02496
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 30, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    K965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE HAS BEEN RETURNED. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS CONFIRMED. THE FINDINGS INDICATE THAT THIS EVENT WAS DUE TO MISHANDLING BY THE END USER. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT ACCORDINGLY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A "HOLE WAS DISCOVERED IN THE HOSE" OF THE HAND PIECE DEVICE DURING SET-UP. THE REPORTER WAS UNABLE TO PROVIDE INFORMATION REGARDING THE PRECISE LOCATION OF THE HOLE, WHETHER OR NOT THERE WAS ANY SOUND, AND IF AIR OR FLUID CAME FROM THE HOLE DURING THE EVENT. THE DEVICE WAS NOT USED IN SURGERY. THE REPORTER STATED THE SCHEDULED SURGICAL PROCEDURE WAS COMPLETED WITHOUT DELAY, AS AN IDENTICAL SPARE DEVICE WAS AVAILABLE. NO PATIENT HARM OR ADVERSE OUTCOME WAS ALLEGED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. IF ANY ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282218 XMAX MOTOR DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1