BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGE ADULT SPREADER 9 1/2

    MDR report key: 3812473 · Received May 15, 2014

    Report

    Report Number
    1226348-2014-11634
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    MDM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THIS IS THE SECOND COMPLAINT OF THIS TYPE FOR THIS PRODUCT CODE AND LOT NUMBER. THE RATCHET MECHANISM DOES NOT APPEAR TO FUNCTION PROPERLY. THE SPRING ACTION ON THE RATCHET IS SLIGHTLY TIGHT NOT ALLOWING FOR PROPER ENGAGEMENT OF THE TEETH MECHANISM ON THE HANDLE. THIS DEFECT APPEARS TO BE ASSOCIATED WITH MANUFACTURING PROCESSES. FURTHER EVALUATION PERFORMED BY THE SUPPLIER INDICATED THAT THERE IS NO REQUIREMENT ON THE DRAWING FOR A DEPTH OF THE RATCHET (ONLY THE ANGLE) AND NO PRESSURE SPECIFICATION. THE PIC ONLY ASKS TO VERIFY PROPER LOCKING ACTION OF THE RATCHET MECHANISM. HISTORICALLY ON THIS PRODUCT, WE HAVE NOT HAD A PRESSURE REQUIREMENT. AND THERE HAVE BEEN NO COMPLAINTS IN THE PAST FOR THIS PRODUCT OR ANY FUNCTIONALITY FAILURES FROM (B)(6). THERE HAVE ALSO NOT BEEN ANY RECENT DRAWING CHANGES OR SUPPLIER CHANGE REQUESTS. THE INSTRUMENTS MEET ALL OF OUR OTHER SPECS. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED "THE TWO PRODUCTS CANNOT HOLD THE "SPREAD' THEY JUST COLLAPSE WITH A SMALL PRESSURE. THE HOSPITAL HAS TWO OF THE OLD SAME CODE, AND THEY ARE DIFFERENT IN THE "LOCK". INSTRUMENTS WERE SENT TO (B)(4) FOR FURTHER TESTING ON (B)(4) 2012. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292016 INGE ADULT SPREADER 9 1/2 INSTRUMENT, MANUAL, SURGICAL, GENERAL USE MDM CODMAN & SHURTLEFF, INC. 119

    Patients

    Seq Age Sex Outcome Treatment
    1