BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 8685260 · Received June 10, 2019

    Report

    Report Number
    1045834-2019-53781
    Event Type
    Malfunction
    Date Received
    June 10, 2019
    Date of Event
    January 1, 2019
    Report Date
    April 8, 2019
    Manufacturer
    DEPUY SYNTHES PRODUCTS LLC
    Product Code
    HBC
    UDI-DI
    00845384002055
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS EVALUATED AND IT WAS REPORTED CONDITION WAS CONFIRMED. THE TORN CORD WAS DETERMINED TO BE CONSISTENT WITH MISHANDLING OF THE DEVICE BY ALLOWING THE CORD TO COME IN CONTACT WITH A SHARP OBJECT WHICH PUNCTURED THE CORD OR EXERTING EXTREME FORCE ON THE CORD DURING CLEANING OR USE. THE ISSUE WITH THE DAMAGED LOCKING COMPONENTS WAS CONSISTENT WITH TRYING TO RUN THE DEVICE IN THE LOAD POSITION OR PUSHING ON THE DISCONNECT SLEEVE WHILE THE DEVICE WAS RUNNING WHICH IS USER ERROR. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT THE MOTOR DEVICE WAS NOT WORKING. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE CORD WAS TORN, THE DEVICE RAN IN THE LOAD POSITION, THE SET SCREW WAS LOOSE AND THE LOCKING COMPONENTS WERE DAMAGED ALLOWING THE DEVICE TO RUN IN THE LOAD POSITION. THE DEVICE ALSO FAILED PRE-TEST FOR SAFETY ASSESSMENT. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2019. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477870 EMAX 2 PLUS MOTOR MOTOR, DRILL, ELECTRIC - HANDPIECE HBC DEPUY SYNTHES PRODUCTS LLC 00845384002055

    Patients

    Seq Age Sex Outcome Treatment
    1