BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CETERIX DISPOSABLE SUTURE PASSER

    MDR report key: 4924216 · Received July 16, 2015

    Report

    Report Number
    3009131204-2015-00004
    Event Type
    Injury
    Date Received
    July 16, 2015
    Date of Event
    June 11, 2015
    Report Date
    July 14, 2015
    Manufacturer
    CETERIX ORTHOPAEDICS
    Product Code
    LHX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL COMPLAINT WAS RECEIVED BY CETERIX ON (B)(6) 2015 WHERE IT WAS REPORTED THAT DURING THIS SURGERY, CETERIX DISPOSABLE SUTURE PASSER LOT # M140157 HAD AN UPPER JAW BREAK. CETERIX DISPOSABLE SUTURE PASSER LOT # M140157 WAS RETURNED TO CETERIX FOR INVESTIGATION. VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THE UPPER JAW BREAK. FUNCTIONAL TESTING WAS PERFORMED AND ALL SPECIFICATIONS AND FUNCTIONAL TESTING WAS PERFORMED AND ALL SPECIFICATIONS AND FUNCTIONAL REQUIREMENTS THAT COULD BE TESTED WITH THE UPPER JAW MISSING WERE MET. A LOT HISTORY REVIEW WAS ALSO PERFORMED, AND NO MANUFACTURING RELATED ISSUES WERE IDENTIFIED WHICH WOULD AFFECT THE DEVICE FUNCTIONALITY DURING USE. PROBABLE ROOT CAUSE OF THE UPPER JAW BREAK WAS DETERMINED TO BE EXCESSIVE TORQUE USED DURING DEVICE APPLICATION. THE IFU WARNS AGAINST FORCING THE DEVICE INTO TIGHT SPACES AND THAT EXCESSIVE PUSHING, TWISTING OR LEVERING MAY CAUSE BREAKAGE. AFTER THE METAL FRAGMENT WAS REMOVED FROM THE PATIENTS KNEE, IT WAS RETURNED TO CETERIX FOR EVALUATION. ANALYSIS CONFIRMED THAT THE FRAGMENT WAS LIKELY TO HAVE COME FROM THE UPPER JAW PIN/HINGE OF THE PREVIOUSLY INVESTIGATED CETERIX DISPOSABLE SUTURE PASSER LOT # M140157. A REVIEW OF COMPLAINTS WAS PERFORMED, AND NO OTHER CASES OF JAW PIN/HINGE FRAGMENTS BEING FOUND POST OP WERE FOUND.

    Description of Event or Problem · 1

    AFTER A (B)(6) 2015 PROCEDURE USING THE CETERIX SUTURE PASSER, THE PATIENT EXPERIENCED KNEE PAIN, SWELLING AND A CATCHING SENSATION WHEN GOING DOWN STAIRS. THE SURGEON ORDERED AN X-RAY, WHERE A SMALL METAL FRAGMENT WAS FOUND. A SUBSEQUENT PROCEDURE ON (B)(6) 2015 WAS PERFORMED TO REMOVE THE METAL FRAGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463826 CETERIX DISPOSABLE SUTURE PASSER SUTURE PASSER LHX CETERIX ORTHOPAEDICS CTX-A100 M140157

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention