BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVICE FOR NAIL FIXATION

    MDR report key: 4924375 · Received July 16, 2015

    Report

    Report Number
    9615741-2015-00033
    Event Type
    Malfunction
    Date Received
    July 16, 2015
    Report Date
    June 24, 2015
    Manufacturer
    NEWDEAL SAS
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 09/15/2015. THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE. REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINTS HISTORY. RESULTS: PRODUCTS WERE RETURNED FOR EVALUATION. ALIGNMENT JIG MEETS THE INSPECTION REQUIREMENTS A REVIEW OF THE DESIGN SPECIFICATIONS AND DESIGN CHANGES WAS PERFORMED. NO SIGNIFICANT DESIGN CHANGE ON DIMENSIONS LINKED TO THE ASSEMBLY. NO ANOMALY WAS FOUND REGARDING THIS INCIDENT. A REVIEW OF THE COMPLAINT SYSTEM WAS PERFORMED. THIS IS THE THIRD INCIDENT REPORTED ABOUT A MISALIGNMENT OF PANTA NAIL WITH CALCANEUS SCREWS FOR THE PAST TWO YEARS. THE COMPLAINT RATE FOR THIS KIND OF INCIDENT (CONFIRMED INCIDENTS ONLY) DURING THE STATED TIME PERIOD IS (B)(4)PERCENT. CONCLUSION: GIVEN THE DESCRIPTION OF THE EVENT AND THE OBSERVATIONS MADE DURING THE INVESTIGATION, THE ROOT CAUSE OF MISALIGNMENT CANNOT BE DETERMINED. INCIDENT WAS NOT REPRODUCED, NO ANOMALY WAS FOND ON QUALITY RECORDS.

    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 UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THIS IS THE FIRST OF 2 REPORTS RELATED TO THE SAME EVENT. IT WAS REPORTED THE CALCANEAL SCREWS MISSED GOING INSIDE THE NAIL IN THE CALCANEUS. THIS WAS IDENTIFIED WHEN THE SURGEON TOOK FINAL X-RAYS. THE SURGEON REMOVED THE ENTIRE NAIL AND ALL SCREWS AND STARTED OVER. THE CALCANEAL SCREWS WENT INTO THE NAIL WITH A FEW MORE ATTEMPTS. THE SURGERY WAS DELAYED FOR 1 HOUR. IT WAS REPORTED THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464414 DEVICE FOR NAIL FIXATION PANTA NAIL LXH NEWDEAL SAS E1LV/1

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR