BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFT IMPACT MALLET W/ EASY GRIP HANDLES

    MDR report key: 3572125 · Received January 2, 2014

    Report

    Report Number
    1833053-2013-00009
    Event Type
    Malfunction
    Date Received
    January 2, 2014
    Date of Event
    October 4, 2013
    Report Date
    December 26, 2013
    Manufacturer
    MEDTORQUE INC.
    Product Code
    HXL
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    WHILE IN USE DURING SURGERY, THE DELRIN HEAD OF THE MALLET BROKE OFF. THE DELRIN HEAD WAS FOUND AND THE DEVICE SEQUESTERED. NO INJURIES WERE SUSTAINED BY THE PATIENT. THE USER FACILITY WAS INFORMED THAT THE PART NUMBER HAD UNDERGONE A DESIGN CHANGE TO ALLOW ENHANCED IMMOBILITY UPON IMPACT. TO ACCOMPLISH THIS, THE RE-DESIGN INCORPORATED A METAL INSERT WITHIN THE THREADS OF THE HEADS TO CREATE A MORE TIGHT GRIP. NOTE THAT THE DESIGN CHANGE WAS ALREADY IN PROCESS WHEN THIS EVENT OCCURRED. THE USER FACILITY WAS ISSUED TWO LOANER DEVICES TO USE UNTIL THE DESIGN CHANGE PROCESS WAS COMPLETE. AFTER NEW DEVICES WERE MANUFACTURED, REPLACEMENTS WILL BE SENT TO THE CUSTOMER. A FOLLOW UP MESSAGE WAS LEFT REGARDING THE REPLACEMENT DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2649 SOFT IMPACT MALLET W/ EASY GRIP HANDLES HXL MEDTORQUE INC. 7832 1012MT

    Patients

    Seq Age Sex Outcome Treatment
    1