BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 3811219 · Received October 11, 2013

    Report

    Report Number
    1045834-2013-06507
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Date of Event
    February 21, 2011
    Report Date
    March 10, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REC'D BY DEPUY SYNTHES POWER TOOLS. RELIABILITY ENGINEERING EVALUATED THE DEVICE, AND THE REPORTED PROBLEM OF "MOTOR SPINS FREE" WAS CONFIRMED; THE LOCKING MECHANISM OF THE MOTOR EXHIBITED THAT IS CONSISTENT WITH IMPROPER ASSEMBLY OF AN ATTACHMENT INTO THE MOTOR. THE MOTOR PAWLS WERE DAMAGED, ALLOWING THE MOTOR DRIVE SHAFT TO SPIN INDEPENDENTLY OF AN ATTACHMENT DRIVE SHAFT OR CUTTING BURR WHEN PRESSURE WAS APPLIED. IF ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. REF: (B)(4).

    Description of Event or Problem · 1

    REPORT REC'D FROM (B)(6) STATING THAT THE DEVICE MOTOR SPINS FREE. DEVICE WAS NOT USED IN SURGERY. IT IS UNK IF INJURY OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524164 EMAX 2 PLUS MOTOR MOTOR, DRILL, ELECTRIC - HANDPIECE, PRODUCT CODE: HBC HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1