BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVICE FOR NAIL FIXATION

    MDR report key: 3327237 · Received August 19, 2013

    Report

    Report Number
    9615741-2013-00038
    Event Type
    Malfunction
    Date Received
    August 19, 2013
    Date of Event
    July 31, 2013
    Report Date
    August 19, 2013
    Manufacturer
    NEW DEAL SAS
    Product Code
    HSB
    PMA / PMN Number
    K091788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THIS IS THE FIRST REPORT OF THREE (3) FOR THE SAME SURGICAL PROCEDURE ON THE SAME PT. IT WAS REPORTED THAT DURING SURGERY THE PANTA DEVICE FOR NAIL FIXATION DID NOT FIT EASILY ONTO THE PANTA COMPRESSION DEVICE AND COULD NOT BE REMOVED BY RELEASING COMPRESSION AND BACKED OUT ON ONE SIDE ONLY AND GOT STUCK. NO INJURY WAS ALLEGED. SURGERY TIME WAS INCREASED BY 30 MINUTES. IT WAS REPORTED THAT THE SET PROVIDED FOR THE SURGERY HAD THE WRONG DRILLS SUPPLIED FOR THE COMPRESSION RODS WHICH LEAD TO PROBLEMS DURING THE APPLICATION OF COMPRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399365 DEVICE FOR NAIL FIXATION PANTA NAIL HSB NEW DEAL SAS F3GD

    Patients

    Seq Age Sex Outcome Treatment
    1