BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANTA INSTRUMENT SET

    MDR report key: 3231793 · Received July 15, 2013

    Report

    Report Number
    9615741-2013-00028
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    June 21, 2013
    Report Date
    July 15, 2013
    Manufacturer
    NEWDEAL S.A.S.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING DEVICE WAS ALSO INVOLVED IN THE SAME SURGERY: PRODUCT ID: PANTAINST, LOT NUMBER PANTA-047. TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THREADED AXIS THREADS WERE SHREDDED AND THE SUPPORT DEVICE WAS LOCKED UP. THE SURGEON TRIED SO HARD TO GET THE COMPRESSION WHEEL OFF OF IT THAT HE BROKE ONE OF THE HANDLES OFF. IN ADDITION, THE INNER STEEL JIG WOULD NOT COMPRESS AND WAS EXTREMELY DIFFICULT TO INSERT. ADDITIONAL INFORMATION WAS REQUESTED AND ON (B)(6) 2013, THE FOLLOWING WERE RECEIVED. ON (B)(6) 2013, (B)(6) OLD MALE PATIENT UNDERWENT AN ANKLE FUSION PROCEDURE. THE DEVICE PROBLEM REPORTED OCCURRED DURING USE OF THE JIG/COMPRESSION AND REMOVAL OF THE JIG. THERE WAS A SURGICAL DELAY OF 10 MINUTES. A BACK UP SET (PANTAINST, LOT NUMBER PANTA-047) WAS AVAILABLE AND EVERYTHING WAS SWITCHED OUT. HOWEVER, IT WAS NOTED THAT THE INTERNAL JIGS WITH THE COMPRESSION DEVICE SEEM TO STICK MORE. SURGERY WAS ABLE TO BE COMPLETED. PATIENT OUTCOME WAS REPORTED AS TOO SOON TO TELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326007 PANTA INSTRUMENT SET NA LXH NEWDEAL S.A.S. PANTA-008

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR