BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNAP-OFF SCREW 2.7MM LENGTH 12MM

    MDR report key: 3963487 · Received May 30, 2014

    Report

    Report Number
    9615741-2014-00026
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    April 23, 2014
    Report Date
    May 7, 2014
    Manufacturer
    NEWDEAL SAS
    Product Code
    HWC
    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 AHS BEEN INITIATED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THIS IS THE SECOND REPORT OF THREE REPORTS CONCERNING THE SAME PATIENT AND SAME SURGERY. SEE MFG REPORT NUMBER 9615741-2014-00025. THIS REPORT CONCERNS PRODUCT ID 117012ND. IT WAS REPORTED THERE WAS AN ISSUE WITH THE HALLUFIX SCREW. THE PRODUCT WAS IN CONTACT WITH THE 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 THE 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 THE SCREW (THE SCREW COULD TURN IN THE BONE). THERE WAS NO REPORTED ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319965 SNAP-OFF SCREW 2.7MM LENGTH 12MM HALLU-FIX HWC NEWDEAL SAS FF6Y2

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR