BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIN&WIRE FRONT/SIDE TC

    MDR report key: 2433643 · Received January 10, 2012

    Report

    Report Number
    2523190-2012-00006
    Event Type
    Malfunction
    Date Received
    January 10, 2012
    Report Date
    January 10, 2012
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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

    DOCTOR REPORTED VIA PHONE THAT THE TIP OF INSTRUMENT FRAGMENTED DURING NAIL PLATE (FINGER NAIL) REMOVAL AND CLOSED REDUCTION PROXIMAL PERCUTANEOUS PINNING OF P3 (PHALANX) FRACTURE - DOCTOR WAS ABLE TO REMOVE PIECES. THE DEBRIS WAS REMOVED USING IRRIGATION OF THE WOUND. AN INFECTION OCCURRED NOT NECESSARILY DUE TO THE EVENT AND WAS TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIN&WIRE FRONT/SIDE TC M10 - ORTHOPEDIC LXH INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1