BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUINOXE

    MDR report key: 17034785 · Received May 31, 2023

    Report

    Report Number
    1038671-2023-01190
    Event Type
    Malfunction
    Date Received
    May 31, 2023
    Date of Event
    July 25, 2022
    Report Date
    May 31, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION # AND DESCRIPTION: (B)(4), (B)(4), CAPA2020-15. FINDINGS: PER CAPA2020-15: 750-2010-031-DIR-INSTRUMENTS DESIGN INPUT-OUTPUT MATRIX FOR HUMERAL HEAD RECONSTRUCTION PROSTHESIS INSTRUMENTS WAS REVIEWED TO COMPILE COMPLETED VERIFICATIONS AND VALIDATIONS. THE DESIGN CONTROL DOCUMENT HAD LIMITED USER NEEDS, LEADING TO DESIGN INPUTS THAT ADDRESSED FUNCTIONAL AND INTERFACE/COMPATIBILITY REQUIREMENTS BUT HAD NO SPECIFIC PERFORMANCE REQUIREMENTS FOR THE MIDDLE SEGMENT TRIALS. THE DHR WAS REVIEWED. THE INSPECTION RESULTS SHOW THAT THERE WERE ZERO NON-CONFORMITIES IDENTIFIED DURING INSPECTION, INDICATING THAT THE REPORTED EVENTS WERE NOT A RESULT OF A NONCONFORMANCE IDENTIFIED DURING INSPECTION OF THE DEVICES. THE DEVICES ARE MANUFACTURED BY BCS MACHINE. THE VENDOR DOCUMENTS WERE ATTACHED TO THE DHRS. THE MANUFACTURING DOCUMENTATION INDICATED THAT THERE WERE NO NON-CONFORMITIES DURING THE MANUFACTURE OF THE DEVICES THAT WOULD HAVE RESULTED IN THE REPORTED EVENTS. THE ROOT CAUSE OF THE REPORTED EVENT WAS ANALYZED UTILIZING SOP 701-103-742 AND DOCUMENTED ON FORM 701-104-796. METHOD WAS DETERMINED TO BE THE PRIMARY ROOT CAUSE OF THE REPORTED EVENT WITH CONTRIBUTING FACTORS OF ENVIRONMENT, MATERIAL, AND MAN, AS EXPLAINED IN FURTHER DETAIL BELOW. MAN: EXCESSIVE FORCE APPLIED DURING THE OPERATIVE TECHNIQUE MAY CAUSE STRESS ON THE DEVICE, WHICH COULD RESULT IN FAILURE (AS REPORTED IN THE EVENT) MATERIAL: MATERIAL DURABILITY WITH REGARDS TO FORCE APPLIED AND STERILIZATION/REPROCESSING DURING LIFETIME OF USE FOR INTENDED USE ENVIRONMENT: HEATS AND PRESSURES APPLIED DURING REPEATED STERILIZATION/DISINFECTION MAY HAVE CONTRIBUTED TO MATERIAL DEGRADATION OVER TIME. MOST LIKELY UNDERLYING CAUSE/ROOT CAUSE: AS DETERMINED BY CAPA2020-15, THE BROKEN INSTRUMENT REPORTED IN CASE-(B)(4) WAS LIKELY THE RESULT OF NOT CONSIDERING SPECIFIC PERFORMANCE REQUIREMENTS TO CAPTURE USER NEEDS AND DESIGN INPUTS (MATERIAL DURABILITY DURING REPROCESSING/STERILIZATION AS WELL AS FORCE APPLIED OVER LIFETIME OF DEVICE), WHICH LED TO INSUFFICIENT TESTING TO DEMONSTRATE CONTINUED PERFORMANCE OVER TIME AND RESULTED IN FRACTURE DURING SURGICAL USE. CORRECTIVE ACTION TAKEN: ACTION PLAN TO ADDRESS IMMEDIATE ISSUE WILL BE HANDLED UNDER CAPA2020-15. SYSTEMIC ISSUE(S) WILL BE ADDRESSED UNDER CAPA 2020-02. CAPA2020-15 CORRECTIVE ACTIONS: DIR WILL BE TRANSFERRED TO THE NEW DTM FORM. DTM WILL BE REVISED TO UPDATE USER NEEDS AND DESIGN INPUTS IN ACCORDANCE WITH WI 701-105-187. VERIFICATION AND VALIDATION ACTIVITIES WILL BE UPDATED AS NEEDED. GENERAL DESIGN REVIEW WILL BE.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM AUSTRALIA THAT INSTRUMENT ITEM #309-10-25 WAS RETURNED FROM THE HOSPITAL AS DAMAGED. THE NEED FOR A REPLACEMENT STOCK ORDER WAS MENTIONED IN THE COMMUNICATION, IN ADDITION TO A REQUEST TO RELEASE THE ITEM BASED ON THE ATTACHED SAS APPROVAL. IT WAS ALSO REPORTED THAT DURING SURGICAL USE, UPON REMOVAL OF TRIAL SEGMENT FROM STEM INSITU, THE 4 ¿LEGS¿ OF THE TRIAL BROKE. THE PIECES WERE RETRIEVED FROM THE WOUND SITE AND ACCOUNTED FOR. RELEVANT X-RAYS WERE UNABLE TO OBTAINED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030846 EQUINOXE PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male Other UNK.