BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KATOR SUTURE ANCHOR 5MM X 25MM, #2 SUTURE, ARTHROSCOPIC

    MDR report key: 7385921 · Received March 30, 2018

    Report

    Report Number
    3012103994-2018-00001
    Event Type
    Malfunction
    Date Received
    March 30, 2018
    Date of Event
    March 23, 2018
    Report Date
    March 29, 2018
    Manufacturer
    KATOR LLC
    Product Code
    MBI
    PMA / PMN Number
    K162386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING ARTHROSCOPIC ROTATOR-CUFF-REPAIR SURGERY, THE BREAKAWAY HEAD ON THE SUTURE ANCHOR BROKE PREMATURELY AND PRIOR TO SUTURE LOCK OUT. THE ANCHOR AND LOCKING PIN WERE REMOVED AND THE SUTURES WERE UNTHREADED FROM THE ANCHOR. A SECOND ANCHOR WAS PLACED AND THE LOCKING PIN DEPLOYED HALFWAY. THE SUTURES WERE RETAINED BY THE SECOND ANCHOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228600 KATOR SUTURE ANCHOR 5MM X 25MM, #2 SUTURE, ARTHROSCOPIC SUTURE ANCHOR MBI KATOR LLC 103-0592 0095

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR