BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APERFIX AM

    MDR report key: 5381377 · Received January 20, 2016

    Report

    Report Number
    3006108336-2016-00001
    Event Type
    Malfunction
    Date Received
    January 20, 2016
    Date of Event
    December 10, 2015
    Report Date
    December 31, 2015
    Manufacturer
    CAYENNE MEDICAL, INC
    Product Code
    MBI
    PMA / PMN Number
    K122463
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CAYENNE MEDICAL WAS NOTIFIED ON 12/31/2015 THAT DURING AN ACL RECONSTRUCTION SURGERY CASE, THE SALES REPRESENTATIVE NOTICED THAT THE END POTION OF THE CENTRAL SCREW IN THE IMPLANT HAD BROKEN OFF AND WAS STILL ATTACHED TO THE INSERTER. IT WAS ALSO REPORTED THAT THE SURGEON FACED SOME DIFFICULTIES DURING REMOVAL OF THE INSERTER WHERE THE PURPLE KNOB WOULD NOT PULL BACK TO DISENGAGE THE INSERTER FROM THE DEPLOYED IMPLANT AND THEREFORE, THE SURGEON HAD TO GIVE THE WHITE DEPLOYMENT KNOB AN ADDITIONAL TURN(S) AND THAT POINT AN ABNORMAL SOUND WAS HEARD BUT THE SOURCE OF THE SOUND COULD NOT BE IDENTIFIED. THE SURGEON WAS ABLE TO REMOVE THE INSERTER. THE SURGEON WAS THEN NOTIFIED BY THE SALES REPRESENTATIVE ABOUT THE SCREW HEAD THAT WAS STILL ATTACHED TO THE INSERTER. THE FAILURE MODE WILL NOT ADVERSELY EFFECT THE PATIENT'S ACL RECONSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38911 APERFIX AM BONE SCREW MBI CAYENNE MEDICAL, INC CM-2410 53293-3

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention