BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOREFOOT IB IMPLANT SYS, PEEK

    MDR report key: 19492935 · Received June 7, 2024

    Report

    Report Number
    1220246-2024-05297
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    February 10, 2023
    Report Date
    June 7, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    UDI-DI
    00888867242081
    PMA / PMN Number
    K051726
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR DUE TO MISALIGNED INSERTION AND/OR IMPROPER BONE PREPARATION.

    Description of Event or Problem · 0

    2/13/2023, IT WAS REPORTED BY SALES REPRESENTATIVE VIA EMAIL THAT THE ANCHOR OF ONE OF THE TENODESIS SCREWDRIVER FROM AN AR-1530P-CP FOREFOOT INTERNALBRACE IMPLANT SYSTEM, WOULD NOT COME OFF THE INSERTER HANDLE. THIS WAS DISCOVERED DURING A PLANTAR PLATE INTERNALBRACE PROCEDURE ON (B)(6) 2023. CASE WAS COMPLETED USING ANOTHER AR-1530P-CP KIT. ADDITIONAL INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031278 FOREFOOT IB IMPLANT SYS, PEEK BONE FIXATION SCREW/PLATE HWC ARTHREX, INC. FOREFOOT IB IMPLANT SYS, PEEK 14364716 00888867242081

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown