BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNAP OFF SCREW DIAM 2.7MM LENG

    MDR report key: 3899288 · Received May 16, 2014

    Report

    Report Number
    9615741-2014-00025
    Event Type
    Malfunction
    Date Received
    May 16, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    NEWDEAL SAS
    Product Code
    LXH
    PMA / PMN Number
    K093781
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE 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 REPORTS CONCERNING THE SAME PATIENT AND SAME SURGERY. THIS CONCERNS PRODUCT ID 117010ND. IT WAS REPORTED THERE WAS AN ISSUE WITH THE HALLUX-FIX SCREW. THE PRODUCT IN CONTACT WITH PATIENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON ON (B)(6) 2014. THE PROCEDURE WAS AN ARTHRODESIS OF THE BIG TOE. THE SURGEON FINISHED THE SURGERY WITH DIFFICULTIES WITH AN INITIAL RESULT LESS SATISFACTORY THAN EXPECTED. THE SURGERY WAS COMPLETED WITH A COMPETITOR MEDICAL DEVICE WHICH WAS AVAILABLE (MINIPLATES SYNTHES). THE SURGERY TIME WAS INCREASED 30 TO 40 MINUTES. THE SCREW "SNAP OFF) DID NOT BREAK AS EXPECTED WHICH RESULTED IN DAMAGE TO THE SCREW (THE SCREW WOULD TURN IN THE BONE). THERE WAS NO REPORTED ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294705 SNAP OFF SCREW DIAM 2.7MM LENG NA LXH NEWDEAL SAS F755

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR