BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVICE FOR NAIL FIXATION

    MDR report key: 2871731 · Received December 11, 2012

    Report

    Report Number
    9615741-2012-00096
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    NEWDEAL SAS
    Product Code
    LXH
    PMA / PMN Number
    K091788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PANTA COMPRESSION DEVICE: PRODUCT NUMBER 519130ND WAS ALSO USED DURING THIS SURGERY. TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE TIBIAL DRILLS DID NOT PASS THROUGH THE PROTECTION GUIDE WHICH MEANS THAT IT PROBABLY DID NOT PASS THROUGH THE NAIL. THE IMPLEMENTATION OF THE COMPRESSION RODS WAS IMPOSSIBLE AND THE TIBIAL SCREWS WERE NOT IMPLANTED DUE TO MISSING TIME. THE NAIL WAS ONLY FIXED IN THE DISTAL PART (CALCANEUM). THE NAIL WAS NOT FIXED IN THE TIBIAL PART. THE PRODUCT WAS IN CONTACT WITH THE PATIENT BUT THERE WAS NO PATIENT INJURY OR DEATH ALLEGED. THE EVENT LEAD TO AN INCREASE OF SURGERY TIME OF 50 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEVICE FOR NAIL FIXATION PANTA NAIL LXH NEWDEAL SAS

    Patients

    Seq Age Sex Outcome Treatment
    1