BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSTITCH CARTRIDGE 2-0

    MDR report key: 8597617 · Received May 9, 2019

    Report

    Report Number
    3009131204-2019-00103
    Event Type
    Malfunction
    Date Received
    May 9, 2019
    Date of Event
    May 2, 2019
    Report Date
    June 4, 2019
    Manufacturer
    CETERIX ORTHOPAEDICS, INC
    Product Code
    GAT
    PMA / PMN Number
    K180531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: LOT # M180126; THE CARTRIDGE USED IN TREATMENT WAS NOT RETURNED FOR EVALUATION, ONLY NEEDLE WITH BROKEN TIP RETURNED. THERE WAS RELATIONSHIP FOUND BETWEEN THE RETURNED NEEDLE AND THE REPORTED INCIDENT. THE ROOT CAUSE FOR THIS EVENT COULD NOT BE DETERMINED WITH CONFIDENCE BECAUSE ONLY NEEDLE WITH BROKEN TIP WAS RECEIVED. THE PROBABLE ROOT CAUSE FOR THE NEEDLE TIP FRACTURE IS WHEN SURGEON CYCLES NEEDLE TOO MANY TIMES, OR ADVANCES NEEDLE WITHOUT TISSUE PRESENT BETWEEN DEVICE JAWS. DOUBLE CLUTCH WAS ALSO REPORTED. DOUBLE CLUTCH HAPPENS WHEN DEVICE IS PARTIALLY FIRED, THE SUTURE DOES NOT REACH THE UPPER JAW TO BE CAPTURED. WHEN FIRING THE DEVICE BOTH THE ORANGE AND GREY HANDLE MUST BE FULLY COMPRESSED IN ONE SMOOTH MOTION FOR THE NEEDLE TO DEPLOY THE DEVICE THROUGH THE UPPER JAW TRAP. DO NOT ADVANCE THE BLACK TRIGGER UNTIL YOU ARE READY TO PASS THE SUTURE. ONCE YOU START ADVANCING, YOU HAVE COMMITTED TO THE STITCH. THIS IS A TECHNIQUE RELATED ISSUE AND CAN BE EASILY PREVENTED WITH PROPER DEVICE USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MENISCAL REPAIR SURGERY, THE SURGEON "DOUBLE CLUTCHED" THE DEVICE AND BROKE OFF THE DISTAL TIP OF THE NEEDLE. ALL PIECES WERE REMOVED FROM PATIENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387686 NOVOSTITCH CARTRIDGE 2-0 SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT CETERIX ORTHOPAEDICS, INC M180126

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR