BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSTITCH PRO MENISCAL REPAIR SYSTEM, SIZE 2-0

    MDR report key: 8341010 · Received February 14, 2019

    Report

    Report Number
    3009131204-2019-00007
    Event Type
    Malfunction
    Date Received
    February 14, 2019
    Date of Event
    January 29, 2019
    Report Date
    February 22, 2019
    Manufacturer
    CETERIX ORTHOPAEDICS
    Product Code
    GAT
    UDI-DI
    00853541006112
    PMA / PMN Number
    K180531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER FACILITY RETURNED THE PRODUCTS TO THE MANUFACTURING FACILITY FOR INVESTIGATION. UPON INVESTIGATION, IT WAS FOUND THAT THERE WERE TWO DEVICES THAT WERE USED IN THE CLINICAL CASE. ONE DEVICE WITH LOT NUMBER M180089 AND ANOTHER DEVICE WITH LOT NUMBER M180096 WERE RETURNED. IN ONE DEVICE THE UPPER JAW BROKE AND IN ANOTHER DEVICE THE LOWER JAW BROKE. THE BREAK OF THE UPPER JAW WAS INCLUDED IN THE INITIAL REPORT DATED (B)(6) 2019. THE DEVICE WITH LOT NUMBER M180096 WAS FOUND BROKEN AT THE LOWER JAW WELD. IT IS HIGHLY UNLIKELY FOR THE LOWER JAW TO BREAK IF THE CARTRIDGE IS PROPERLY SEATED IN THE SHAFT. WHEN THE CARTRIDGE IS IMPROPERLY LOADED TO THE DEVICE HANDLE AND THE SURGEON APPLIES EXCESSIVE TORQUE THE CARTRIDGE COULD BREAK. IF THE LOWER JAW FALLS INTO THE PATIENT ANATOMY, IT IS READILY NOTICEABLE TO THE SURGEON AND THE SIZE OF THE LOWER JAW MAKES IT EASILY OBSERVABLE AND RETRIEVABLE. IN THIS CASE, THE LOWER JAW FRAGMENT WAS RETRIEVED DURING PRIMARY PROCEDURE. THERE WAS NO HARM TO THE PATIENT. ATTACHMENT: [(B)(6)_(B)(4) SIGNED.PDF].

    Description of Event or Problem · 0

    THE UPPER JAW OF THE DEVICE BROKE DURING A KNEE ARTHROSCOPIC SURGERY. PATIENT FACTORS AND LOW PORTAL PLACEMENT CONTRIBUTED TO THE UPPER JAW BREAK. THE PATIENT HAD LOTS OF TISSUE AROUND THE PORTAL. THE UPPER JAW CAN BREAK, WHEN THE DEVICE IS JAMMED IN AND OUT OF THE KNEE OR INTO STRUCTURES IN KNEE, OR IF THE SURGEON DOES NOT DEPRESS THE UPPER JAW DURING DEVICE INSERTION. THE BROKEN FRAGMENT WAS RETRIEVED FROM THE PATIENT'S KNEE DURING PRIMARY PROCEDURE.

    Description of Event or Problem · 1

    THE UPPER JAW OF THE DEVICE BROKE DURING A KNEE ARTHROSCOPIC SURGERY. PATIENT FACTORS AND LOW PORTAL PLACEMENT CONTRIBUTED TO THE UPPER JAW BREAK. THE PATIENT HAD LOTS OF TISSUE AROUND THE PORTAL. THE UPPER JAW CAN BREAK, WHEN THE DEVICE IS JAMMED IN AND OUT OF THE KNEE OR INTO STRUCTURES IN KNEE, OR IF THE SURGEON DOES NOT DEPRESS THE UPPER JAW DURING DEVICE INSERTION. THE BROKEN FRAGMENT WAS RETRIEVED FROM THE PATIENT'S KNEE DURING PRIMARY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131415 NOVOSTITCH PRO MENISCAL REPAIR SYSTEM, SIZE 2-0 NOVOSTITCH PRO MENISCAL REPAIR SYSTEM, SIZE 2-0 GAT CETERIX ORTHOPAEDICS M180089 00853541006112

    Patients

    Seq Age Sex Outcome Treatment
    1