BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR, HIGH STRENGTH HOSE

    MDR report key: 3873695 · Received October 11, 2013

    Report

    Report Number
    1045834-2013-15375
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Report Date
    August 28, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    K965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROCESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) STATING THAT THE LOCKING MECHANISM OF THE DEVICE IS NOT FUNCTIONING. IT IS UNKNOWN IF THE DEVICE WAS USED IN SURGERY. IT IS ALSO UNKNOWN IF INJURY OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523317 XMAX MOTOR, HIGH STRENGTH HOSE DRILL, SURGICAL, ENT (PNEUMATIC) - HANDPIECE ERL DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1