BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMMERTOE CORRECTION SYSTEM

    MDR report key: 6280723 · Received January 26, 2017

    Report

    Report Number
    3004154314-2017-00001
    Event Type
    Malfunction
    Date Received
    January 26, 2017
    Date of Event
    December 19, 2016
    Report Date
    December 29, 2016
    Manufacturer
    ARTHROSURFACE, INC.
    Product Code
    HWC
    PMA / PMN Number
    K130859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PARTS WERE RETURNED TO ARTHROSURFACE ENGINEERING DEPARTMENT FOR EVALUATION. NO IMPERFECTIONS OR OTHER PHYSICAL DAMAGES NOTICED ON THE PARTS WHEN VISUALLY EXAMINED UNDER 10X MICROSCOPE. THE OUTER AND INNER SURFACES, THREAD PROFILES OF BOTH SCREWS SHOWED NO CONCERNS. THE PROXIMAL AND DISTAL SCREWS MATED WITH THE 10 DEGREE TAPER LOCK PIN (FERRULE) AS INTENDED. ALSO, THERE WAS NO HINDRANCE TO THE TAPER PIN WHILE LOADING SCREWS ON TO IT. THE ENGINEERING DEPARTMENT BELIEVES THAT THE ONE OF THE SCREWS MIGHT HAVE BEEN PLACED TOO DEEP, WHICH MADE IT DIFFICULT FOR THE SURGEON TO PLACE THE TAPER PIN DUE TO INTERFERENCE WITH THE RESECTED BONE. THE IFU DOCUMENT PROVIDES ADEQUATE DIRECTIONS FOR THE USER TO PLACE THE SCREWS FLUSH WITH RESECTED BONE SURFACE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AND HENCE, THE EXACT CAUSE OF THE REPORTED ISSUE CANNOT BE CONCLUDED. REVIEW OF DEVICE HISTORY RECORDS (DHRS) OF THE FINAL PACKAGE AS WELL AS THE INDIVIDUAL COMPONENTS (PROXIMAL, DISTAL SCREWS AND PINS) INDICATED NO MANUFACTURING DISCREPANCIES SUCH AS SCRAP, REWORK ETC., IT IS IMPORTANT TO NOTE THAT ALL THE 3 IMPLANT PACKAGES USED IN THIS CASE BELONG TO THE SAME LOT. ALSO, THIS IS THE FIRST COMPLAINT FROM THIS LOT TO DATE. A SUPPLEMENTAL MDR WILL BE FILED AFTER THE PARTS ARE RETURNED AND INVESTIGATED.

    Description of Event or Problem · 1

    THE SURGEON DECIDED TO USE TOEMATE IMPLANTS IN TWO TOES OF THE PATIENT. THE SCREWS WERE SUCCESSFULLY PLACED AND ENGAGED IN THE FIRST TOE. THE SURGEON COULD NOT ENGAGE THE SCREWS WITH THE TAPER PIN IN THE SECOND TOE. PER THE REP, THE SURGEON FELT SOMETHING WAS IMPEDING THE TAPER PIN FROM LOCKING. AS A THIRD TOEMATE IMPLANT PACKAGE WAS READILY AVAILABLE, THE SURGEON IMPLANTED AND ENGAGED THE SCREWS IN THE SECOND TOE WITHOUT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61376 HAMMERTOE CORRECTION SYSTEM SCREW, FIXATION, BONE HWC ARTHROSURFACE, INC. 9H00-T030 75GE3019

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR