BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMMERLOCK

    MDR report key: 4466379 · Received November 3, 2014

    Report

    Report Number
    1649263-2014-00004
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    September 4, 2014
    Report Date
    October 31, 2014
    Manufacturer
    BIOMEDICAL ENT., INC.
    Product Code
    HTY
    PMA / PMN Number
    K131640
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ON 10/28/2014, BME RECEIVED INFORMATION FROM DR. (B)(6) TO CONCLUDE COMPLAINT INVESTIGATION OPENED ON (B)(6) 2014. HE PROVIDED THE FOLLOWING DETAILS. THE CASE INVOLVED AN ARTHRODESIS OF THE THIRD HAMMERTOE (CAN'T RECALL WHICH FOOT). HE PREPARED AND REAMED THE ENDS PER INSTRUCTIONS. THE PROXIMAL END WAS INSERTED WITHOUT EVENT. HOWEVER, WHEN HE REMOVED THE HAMMERLOCK (X-TYPE MEDIUM) DISTAL PRONG COVER, IT HAD ALREADY DEPLOYED. PER DR. (B)(6), SALES REPRESENTATIVE ADVISED HIM TO DEPRESS THE DISTAL PRONGS WITH A CLAMP TO CLOSE. THE PRONGS WOULD NOT DEPRESS COMPLETELY, HE FORCED THE DISTAL END INSERTION AND IN PROCESS, FRACTURED THE LATERAL INTERIOR CORTEX. UPON THIS, HE REMOVED THE IMPLANT AND FIXED SITE WITH KWIRE. HE STATES THE IMPLANT WAS STORED APPROPRIATELY. THE PATIENT EXPERIENCED NO DELAY IN PROCEDURE AND RECOVERED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705080 HAMMERLOCK HTY PIN, FIXATION, SMOOTH, 21 CFR 888.3040 HTY BIOMEDICAL ENT., INC. HLXM BMEHL135099C

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention