BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMMERLOCK

    MDR report key: 4239332 · Received November 3, 2014

    Report

    Report Number
    1649263-2014-00003
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    December 21, 2011
    Report Date
    November 3, 2014
    Manufacturer
    BIOMEDICAL ENT., INC.
    Product Code
    HTY
    PMA / PMN Number
    K091951
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, BME SALES REGIONAL DIR MENTIONED TO BME SENIOR RESEARCH ENGINEER THAT HE HAD A SURGEON WHO USED A HAMMERLOCK AND THE IMPLANT BROKE THROUGH THE SIDE OF THE PHALANGE. INITIAL INVESTIGATION REVEALED THIS COMPLAINT WAS REPORTED TO BME AROUND (B)(6) 2012 BY MED DEVICE DISTRIBUTOR. AT THAT TIME, THE COMPLAINT WAS EVALUATED AND IT WAS DETERMINED THAT A MEDWATCH REPORT WAS NOT REQUIRED. DETAILS PROVIDED BELOW REFLECT INFO GATHERED IN 2012 AS WELL AS FOLLOW UP DETAILS ACQUIRED (B)(6) 2014. PER CORRESPONDENCE FROM DR. (B)(6), IMPLANT WAS INSERTED WITHOUT INCIDENT TO (B)(6)'S THIRD TOE, LEFT FOOT. PT WAS DISCHARGED WITHOUT COMPLICATION BUT RETURNED TO SURGEON TWO DAYS LATER COMPLAINING OF PAIN. X-RAY REVEALED THAT THE CORTEX WAS BROKEN. THE IMPLANT WAS FULLY DEPLOYED AND WITHIN THE CORTICAL SPACE, PER INSTRUCTIONS; HOWEVER, BME SENIOR RESEARCH ENGINEER REVIEWED THE X-RAYS AND REPORT AND CONCLUDED THAT THE SURGEON PREPARED THE INCISION SITE CORRECTLY, BUT DRILLED AT AN ANGLE, WHEN THE IMPLANT DEPLOYED IT BROKE THROUGH THE CORTICAL WALL. DESPITE THIS, SURGEON ADDED THAT (B)(6) RECOVERED WITHOUT SERIOUS COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703581 HAMMERLOCK HTY BIOMEDICAL ENT., INC. HLXMA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention