BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDON SPACER SWANSON/HUNTER 24CM X 3MM FLEXSPAN

    MDR report key: 22018275 · Received May 14, 2025

    Report

    Report Number
    3010667733-2025-00561
    Event Type
    Malfunction
    Date Received
    May 14, 2025
    Date of Event
    April 15, 2025
    Report Date
    August 19, 2025
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY INC
    Product Code
    HXA
    UDI-DI
    00840420121851
    PMA / PMN Number
    24270003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD BE CONFIRMED SINCE THE DATE THE DEVICE WAS IMPLANTED WAS CONFIRMED TO BE AFTER THE EXPIRATION. THE PRODUCT WAS NOT RETURNED, HOWEVER EVALUATION OF THE DHR AND LABELING DOES CONFIRM THE EXPIRATION DATE WAS CORRECTLY PRINTED ON ALL LABELS. FURTHERMORE, IT WAS NOTED THE DEVICE WAS NOT A LOAN OR A CONSIGNMENT. THE HOSPITAL TEAM KNOWINGLY IMPLANTED AN EXPIRED ITEM SINCE THEY HAD NO OTHERS AVAILABLE. BASED ON THE INVESTIGATION, THE ROOT CAUSE CAN BE ATTRIBUTED A USER RELATED ISSUE. THE SURGEON KNOWINGLY DECIDED TO USE THE PRODUCT OFF-LABEL. IN GENERAL IT CAN BE STATED THAT IN CASE OF THE EXPIRATION OF SHELF LIFE STRYKER CANNOT GUARANTEE THE PERFORMANCE AND SAFETY FOR USE. THE RISK OF INFECTION WILL INCREASE WITH THE TIME PASSED AFTER THE EXPIRY DATE WHICH IS PRINTED ON THE PACKAGING. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF MORE INFORMATION IS PROVIDED, THE CASE WILL BE REASSESSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN EXPIRED IMPLANT WAS IMPLANTED INTO A PATIENT ON (B)(6) 2025 AS PER THE FOLLOWING: THE EXPIRED TENDON SPACER WAS INSERTED INTO THE PATIENT WITH THE SURGEONS KNOWLEDGE AND CONSENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN EXPIRED IMPLANT WAS IMPLANTED INTO A PATIENT ON (B)(6)2025 AS PER THE FOLLOWING - THE EXPIRED TENDON SPACER WAS INSERTED INTO THE PATIENT WITH THE SURGEONS KNOWLEDGE AND CONSENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118641 TENDON SPACER SWANSON/HUNTER 24CM X 3MM FLEXSPAN PROSTHESIS, TENDON, PASSIVE HXA WRIGHT MEDICAL TECHNOLOGY INC 1595956 00840420121851

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown