BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOSTITCH PRO MEN RPR SYS 2-0

    MDR report key: 11783018 · Received May 6, 2021

    Report

    Report Number
    3009131204-2021-00020
    Event Type
    Injury
    Date Received
    May 6, 2021
    Date of Event
    April 16, 2021
    Report Date
    February 9, 2022
    Manufacturer
    CETERIX ORTHOPAEDICS, INC
    Product Code
    GAT
    UDI-DI
    00853541006112
    PMA / PMN Number
    K180531
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: ¿THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION REVEALED ONE DEVICE WAS RETURNED IN THE PRODUCT BOX LABELED WITH LOT M190387. THE LINK CONNECTING THE SHAFT TO THE UPPER JAW WAS BROKEN. A FUNCTIONAL EVALUATION REVEALED THE UPPER JAW CANNOT BE ACTUATED WITH THE TRIGGER. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW CONCLUDED THIS WAS A REPEAT ISSUE. A REVIEW OF RISK MANAGEMENT FILES FOUND THAT THE REPORTED FAILURE WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. THE INSTRUCTION FOR USE ("IFU") DISCUSSES ALL SURGICAL HAZARDS IN WARNING SECTION. IN IFU WARNING NOTES, ¿DO NOT FORCE THE DEVICE INTO TIGHT JOINT SPACES. EXCESSIVE PUSHING, TWISTING OR LEVERING MAY CAUSE BREAKAGE.¿ IT WAS DETERMINED THE DEVICE DID NOT CONTRIBUTE TO THE REPORTED EVENT. THE COMPLAINT WAS CONFIRMED AND THE ROOT CAUSE HAS BEEN ASSOCIATED WITH UNINTENDED USE OF THE DEVICE. THE UPPER JAW LINK CAN BREAK WHEN EXCESSIVE FORCE IS APPLIED DURING USE, IF THE PORTAL PLACEMENT IS LOW, OR JAMMING THE DEVICE IN AND OUT OF THE KNEE OR INTO THE STRUCTURES IN KNEE. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. ¿

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT REFERENCE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ACL, SMALL PIECE OF THE HINGE OF THE NOVOSTITCH PRO MEN BROKE AND THE DISTAL JAW NO LONGER ARTICULATED. ALL PIECES WERE RETRIEVED FROM PATIENT'S BODY. PROCEDURE FINISHED WITH SMITH AND NEPHEW BACKUP DEVICE. NO SURGICAL DELAY OR FURTHER COMPLICATIONS REPORTED TO PATIENT DUE THIS EVENT. 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
    683610 NOVOSTITCH PRO MEN RPR SYS 2-0 SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT CETERIX ORTHOPAEDICS, INC CTX-A003 M190387 00853541006112

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention