BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOSTITCH CARTRIDGE 2-0

    MDR report key: 10784668 · Received November 4, 2020

    Report

    Report Number
    3009131204-2020-00035
    Event Type
    Injury
    Date Received
    November 4, 2020
    Date of Event
    October 7, 2020
    Report Date
    November 17, 2020
    Manufacturer
    CETERIX ORTHOPAEDICS, INC
    Product Code
    GAT
    UDI-DI
    00853541006105
    PMA / PMN Number
    K063778
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10, H2, H3, H6: LOT NUMBER M190284, ONE SPENT CARTRIDGE, USED IN TREATMENT, WAS RETURNED FOR EVALUATION. THE CARTRIDGE WAS RECEIVED WITH DISASSEMBLED NEEDLE ASSEMBLY. OVERALL, THE CARTRIDGE ASSEMBLY INTACT WITH ALL THE COMPONENTS, WITH NO FRAGMENTS MISSING. THERE WAS NO RELATIONSHIP FOUND BETWEEN THE RETURNED CARTRIDGE AND THE REPORTED INCIDENT. THE SUTURE CAN BREAK DURING KNOTTING WHEN SUTURE TENSILE STRENGTH IS INSUFFICIENT TO CARRY APPLIED LOAD. DEVICE DESIGNED WITH SUTURE THAT CONFORMS TO USP 2-0 TENSILE STRENGTH REQUIREMENTS. THE INSTRUCTION FOR USE CONTAINS PRECAUTIONS ABOUT USING OF THE DEVICE UNDER THESE CONDITIONS. BASED ON THE REPORTED ISSUE THE PROBABLE ROOT CAUSE COULD BE RELATED TO SURGEON TECHNIQUE ISSUE, THOUGH IT CANNOT BE CONFIRMED WITH THE INFORMATION AVAILABLE. RISK MANAGEMENT DOCUMENTS WERE REVIEWED FINDING NO ADDITIONAL RISKS THAT REQUIRE TO BE ADDED TO THE REFERENCE DOCUMENT. THE INSTRUCTION FOR USE OUTLINES PRECAUTIONARY STATEMENTS AND INSTRUCTIONS IN REGARDS TO THE USE OF THE DEVICE TO AVOID DAMAGE OR NON-FUNCTIONALITY. A REVIEW OF THE COMPLAINT AND MANUFACTURING RECORDS WAS PERFORMED AND THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY THE NOVOSTICH BROKE WHILE KNOTTING, SUTURE WAS REMOVED WITH GRASPERS; THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1249467 NOVOSTITCH CARTRIDGE 2-0 SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT CETERIX ORTHOPAEDICS, INC CTX-R001 M190284 00853541006105

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention