BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTO

    MDR report key: 3983885 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-16128
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    October 5, 2012
    Report Date
    October 8, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    K965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES. THE DEVICE IS CURRENTLY UNDERGOING EVALUATION. ONCE THE EVALUATION HAS BEEN COMPLETED OR IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE SENT. REF: (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE USA, STATING THAT THE DEVICE WILL NOT LOCK THE BITS IN PLACE. THE DEVICE WAS BEING USED DURING SURGERY. THERE ALSO WAS NO REPORT OF USER OR PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663268 XMAX MOTO ERL DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1