BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVICE FOR NAIL FIXATION

    MDR report key: 3181607 · Received June 14, 2013

    Report

    Report Number
    9615741-2013-00023
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 28, 2013
    Report Date
    June 14, 2013
    Manufacturer
    NEWDEAL SAS
    Product Code
    LXH
    PMA / PMN Number
    K091788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PLASTIC JIG DURING A TIBIOTALOCALCANEAL (TTC) FUSION ON (B)(6) FEMALE PT. WHEN THEY INSERTED THE METAL COMPRESSION COMPONENT AND STARTED TO ZERO IT OUT, THE ALIGNMENT WAS OFF, MEANING ONE SIDE READ TWO (2) AND THE OTHER ZERO (0). HENCE, IT HAD TO BE MANUALLY ZEROED OUT. ALSO, THE METAL AXIS WAS STUCK IN THE PLASTIC JIG AND WILL NOT BACK OUT. THERE WAS PT CONTACT BUT NO PT INJURY. THERE WAS A SURGICAL DELAY OF 10 MINS. THE PRODUCT PROBLEM OCCURRED MID WAY DURING THE SURGERY. THE PROCEDURE WENT FINE AND THEY DID NOT MISS ANY OF THE TIBIA SCREW HOLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272184 DEVICE FOR NAIL FIXATION NA LXH NEWDEAL SAS F52J

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR