BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMMERLOCK

    MDR report key: 3899320 · Received June 5, 2014

    Report

    Report Number
    1649263-2014-00002
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    April 1, 2012
    Report Date
    June 4, 2014
    Manufacturer
    BIOMEDICAL ENT., INC.
    Product Code
    HTY
    PMA / PMN Number
    K091951
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ON GOING, TESTING IS BEING CONDUCTED BY ENGINEERING TEAM.

    Description of Event or Problem · 1

    A SURGEON REPORTED A PRODUCT PROBLEM (BROKEN IMPLANT). THE SURGERY WAS PERFORMED ON (B)(6) 2012. FOLLOW-UP VISIT ON (B)(6) 2012 REVEALED A BROKEN HAMMERLOCK IMPLANT IN THE LEFT 2ND PIP JOINT. THE IMPLANT WAS REMOVED DUE TO SWELLING AND DISCOMFORT. SALES MANAGER WHO WAS NOTIFIED ABOUT HIS INCIDENT DOES NOT HAVE A PART NUMBER OR A LOT NUMBER. THE IMPLANT WAS GIVEN TO SALES MANAGER BY THE DOCTOR IN A SMALL JAR WITHOUT A LABEL. HE IS SHIPPING THE IMPLANT BACK TO BIOMEDICAL ENTERPRISES INC FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330246 HAMMERLOCK HAMMERLOCK X-TYPE SMALL HTY BIOMEDICAL ENT., INC. HAMMERLOCK HLXS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention