BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COTTLE MALLET, FLAT NYLON FACE

    MDR report key: 888481 · Received August 2, 2007

    Report

    Report Number
    1423507-2007-00085
    Event Type
    Malfunction
    Date Received
    August 2, 2007
    Date of Event
    July 3, 2007
    Report Date
    August 1, 2007
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GFJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE INSTRUMENT RECEIVED FOR EVALUATION. UPON INSPECTION, IT WAS NOTED THAT THE PLASTIC REPLACEABLE TIP WAS WORN. ALSO NOTED WERE SCRATCHES AND SIGNS OF NORMAL WEAR AND TEAR. A DEVICE HISTORY REVIEW WAS CONDUCTED WITH NO ISSUES NOTED. IT WAS DETERMINED THAT THIS DEVICE WAS MANUFACTURED IN 1999. A HISTORICAL COMPLAINT REVIEW WAS ALSO CONDUCTED WITH NO TREND FOUND FOR THIS TYPE OF COMPLAINT ON THIS PRODUCT CODE. DURING THE DEVICE LABELING REVIEW, IT WAS DETERMINED THAT THE LABELING STATES, "NOTE THAT AN EXAMINATION OF ALL INSTRUMENTS IS RECOMMENDED PRIOR TO USE IN ORDER TO DECREASE THE POTENTIAL FOR PATIENT INJURY". ALTHOUGH THE EXACT CAUSE OF THE DAMAGE CANNOT BE DETERMINED. IT IS POSSIBLE THAT THE DAMAGE WAS DUE TO EXCESSIVE FORCES BEING APPLIED.

    Description of Event or Problem · 1

    NYLON FLAKES FROM MALLET FELL OFF INTO PATIENT DURING THE PROCEDURE. ADDITIONALLY, THEY RETRIEVED THE TIP AND IT WAS UNCLEAR WHETHER ANY PARTICLES GOT IN THE SURGICAL SITE, BUT THEY IRRIGATED THE SITE AND DIDN'T SEE ANYTHING. THE PATIENT WAS PUT ON ANTIBIOTICS AFTERWARD AS A PRECAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COTTLE MALLET, FLAT NYLON FACE MALLET GFJ CARDINAL HEALTH RH1541 H99

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR