BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHRO BIOINDCTIVE IMPLANT 1 LARGE

    MDR report key: 11716077 · Received April 23, 2021

    Report

    Report Number
    3003604053-2021-00168
    Event Type
    Injury
    Date Received
    April 23, 2021
    Date of Event
    April 6, 2021
    Report Date
    January 16, 2024
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    OWY
    UDI-DI
    00885556732922
    PMA / PMN Number
    K140300
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT IT IS NOT IN ITS ORIGINAL PACKAGING. THE INSERTION DEVICE AND USED BIOINDUCTIVE IMPLANT WERE RETURNED. THERE IS BIOLOGICAL DEBRIS ON THE RETURNED ITEMS. A FUNCTIONAL ASSESSMENT OF THE INSERTION DEVICE FOUND IT ACTUATES AS INTENDED. THE BIOINDUCTIVE IMPLANT CANNOT BE TESTED AS IT WAS PREVIOUSLY DEPLOYED. A COMPLAINT HISTORY REVIEW FOUND NO SIMILAR REPORTED EVENTS. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. THE INSTRUCTIONS FOR USE WAS REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. THE ROOT CAUSE COULD NOT BE DETERMINED. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE EXCESSIVE FORCE ON THE DEVICE, EXCESSIVE TORQUE ON THE DEVICE, ATTEMPTED CORRECTION OF A DAMAGED DEVICE, OFF-AXIS INSERTION, IMPROPER PREPARATION OF THE INSERTION SITE, OR AN INADVERTENT IMPACT EVENT INCONSISTENT WITH NORMAL USE. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT REFERENCE CASE-(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, AN ARTHRO BIOINDCTIVE IMPLANT LARGE WAS LOADED INTO INSERTER. THE CLAM SHELL WAS A LITTLE STIFF TO REMOVE BUT IMPLANT SEEMED TO BE LOADED PROPERLY. THE DEPLOYMENT OF THE IMPLANT WAS SMOOTH, 5 TENDON ANCHORS WERE PLACED; HOWEVER, THE IMPLANT DID NOT RELEASE FROM THE DELIVERY DEVICE AND PULLED OUT OF THE JOINT. THE PROCEDURE WAS COMPLETED USING A DIFFERENT SIZE BACK-UP DEVICE WITH A DELAY OF 30 MINUTES OR LESS. NO PATIENT INJURY OR 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
    611904 ARTHRO BIOINDCTIVE IMPLANT 1 LARGE MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON OWY SMITH & NEPHEW, INC. RC2AN19J2 00885556732922

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention