BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROMAX-PLUS MOTOR ASSY

    MDR report key: 3970110 · Received December 11, 2013

    Report

    Report Number
    1045834-2013-14558
    Event Type
    Malfunction
    Date Received
    December 11, 2013
    Date of Event
    August 16, 2012
    Report Date
    August 16, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    K965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    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 INFO BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    THE DEVICE WAS RECEIVED FROM (B)(4) FOR SERVICE. DURING SERVICING IT WAS NOTED THAT THE LOCKING MECHANISM OF THE DEVICE WAS NOT FUNCTIONING. IT IS UNK IF THE DEVICE WAS BEING USED DURING SURGERY. IT IS UNK IF THERE WERE INJURIES OR MEDICAL INTERVENTION REPORTED. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648331 MICROMAX-PLUS MOTOR ASSY ERL DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1