BEUDAMED
    FDA Adverse Event Other Summary report: N

    APERFIX AM FEMORAL IMPLANT

    MDR report key: 3115645 · Received May 8, 2013

    Report

    Report Number
    3006108336-2013-00001
    Event Type
    Other
    Date Received
    May 8, 2013
    Date of Event
    March 20, 2013
    Report Date
    May 8, 2013
    Manufacturer
    CAYENNE MEDICAL, INC.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANT REMAINS IN THE PT, SO IT WAS NOT RETURNED FOR EVALUATION. THE SURGEON BELIEVED THE GRAFT FIXATION WAS ACCEPTABLE AND DECIDED NOT TO REVISE THE IMPLANT. ROOT CAUSE ANALYSIS - THE IMPLANT WAS PLACED INTO THE FEMORAL TUNNEL AS USUAL. IT IS UNK WHETHER OR NOT THE SCREW WAS BENT DURING INSERTION AND DEPLOYMENT, SO NO DEFINITIVE ROOT CAUSE CAN BE DETERMINED. IT IS POSSIBLE THAT THE SCREW WAS BENT DURING INSERTION INTO THE FEMORAL TUNNEL, CAUSING ADDED STRESS/STRAIN TO THE SCREW DURING DEPLOYMENT, RESULTING IN FRACTURE.

    Description of Event or Problem · 1

    A 10MM APERFIX AM FEMORAL IMPLANT WAS DEPLOYED IN THE PT ON (B)(6) 2013 AND NOTHING OUT OF ORDINARY WAS NOTED DURING THE SURGERY. NO POST SURGICAL X-RAY WAS TAKEN UNTIL, APPROXIMATELY AFTER 2 WEEKS, AND IT SHOWED THE CENTRAL SCREW OF THE IMPLANT HAD BROKEN. NO ADVERSE EFFECTS WERE NOTED AND THE SURGEON FELT GRAFT RECONSTRUCTION AND INTEGRITY WAS GOOD. THE SURGEON DECIDED TO LEAVE THE IMPLANT IN PLACE AND TAKE NO COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202327 APERFIX AM FEMORAL IMPLANT BONE SCREW HWC CAYENNE MEDICAL, INC. CM-2410 41737-3

    Patients

    Seq Age Sex Outcome Treatment
    1