BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE HINGE TOE IMPLANT W/ GROMMETS #2S

    MDR report key: 14160654 · Received April 20, 2022

    Report

    Report Number
    3010667733-2022-00164
    Event Type
    Malfunction
    Date Received
    April 20, 2022
    Date of Event
    March 22, 2022
    Report Date
    June 13, 2022
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY INC
    Product Code
    KWH
    UDI-DI
    00840420127471
    PMA / PMN Number
    K780132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    CORRECTION D9/H3, H6 METHOD CODE; THE REPORTED EVENT COULD BE CONFIRMED, SINCE THE DEVICE WAS RETURNED WITH THE PROXIMAL GROMMET MISSING AND TWO DISTAL GROMMETS FOUND INSTEAD IN THE PACKAGING. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A MANUFACTURING RELATED ISSUE. THE FAILURE WAS CAUSED BY IMPROPER HANDLING/PACKAGING OF DEVICE. THE CURRENT INSTRUCTIONS FOR USE STATES: "THE SWANSON FLEXIBLE HINGE TOE JOINT GROMMET IS A THIN TITANIUM SHIELD DESIGNED FOR USE WITH THE SWANSON FLEXIBLE HINGE TOE IMPLANT IN RHEUMATOID PATIENTS WHERE CUTTING OR ABRASION OF THE FLEXIBLE IMPLANT FROM CONTACT WITH THIN, SHARP BONE EDGES CAN OCCUR, OR IN PATIENTS WHO HAVE HIGH ACTIVITY LEVELS. IT IS CONTOURED TO CONFORM TO THE SHAPE OF THE MIDSECTION OF THE FLEXIBLE IMPLANT AND IS FABRICATED FROM UNALLOYED TITANIUM FOR SURGICAL APPLICATION. THE DISTAL GROMMET IS USED ON THE DISTAL STEM AND THE PROXIMAL GROMMET IS USED ON THE PROXIMAL STEM TO PROTECT THE IMPLANT FROM BIOMECHANICAL SHEARING FORCES OF SHARP BONE EDGES DURING JOINT MOTION." A NONCONFORMANCE WAS OPENED INTO THIS ISSUE TO FURTHER INVESTIGATE THE PROBLEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SWANSON IMPLANT BOX WAS OPENED, TWO PROXIMAL GROMMETS IN PACKAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SWANSON IMPLANT BOX WAS OPENED, TWO PROXIMAL GROMMETS IN PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186094 FLEXIBLE HINGE TOE IMPLANT W/ GROMMETS #2S PROSTHESIS, TOE, CONSTRAINED, POLYMER KWH WRIGHT MEDICAL TECHNOLOGY INC G4260102 1717547 00840420127471

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown