BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUOHEX CH CANNULATED HAMMERTOE SYSTEM

    MDR report key: 11723495 · Received April 26, 2021

    Report

    Report Number
    3009540749-2021-00010
    Event Type
    Malfunction
    Date Received
    April 26, 2021
    Date of Event
    April 5, 2021
    Report Date
    February 24, 2022
    Manufacturer
    NEXTREMITY SOLUTIONS, INC.
    Product Code
    HWC
    PMA / PMN Number
    K200840
    Removal / Correction Number
    3009540749-2022-001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ROOT CAUSE OF THIS ISSUE WAS DETERMINED TO BE A DESIGN ISSUE WITHIN THE NEXTRA CH DRIVER. NEXTRA CH DRIVERS ARE CONTAINED WITHIN CH-STD-KT AND CH-MINI-KT WHICH HAVE ALL BEEN RECALLED UNDER 3009540749-2022-001 AND HAVE BEEN RETURNED FROM THE FIELD. NO REVISION SURGERY REQUIRED AND THE JOINT FUSED.

    Description of Event or Problem · 0

    POST OP FOLLOW UP TO (B)(6) 2021 BETA FOR NEXTRA CH IMPLANTS WOULD NOT STAY CONNECTED. SURGEON TRIED TO RECONNECT THEM AND THEY WILL NOT STAY TOGETHER. SURGEON TRIED TO CONNECT THEM AND THEY WILL NOT STAY TOGETHER.

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION IS OBTAINED WHICH CHANGES THE OUTCOME OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    POST OP FOLLOW UP TO (B)(6) 2021 BETA FOR NEXTRA CH THE IMPLANTS WOULD NOT STAY CONNECTED. SURGEON TRIED TO RECONNECT THEM AND THEY WILL NOT STAY TOGETHER. PRODUCT REMAINS IMPLANTED AND PATIENT IS BEING MONITORED. NO FURTHER PATIENT INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623844 DUOHEX CH CANNULATED HAMMERTOE SYSTEM SCREW HWC NEXTREMITY SOLUTIONS, INC. 1574801, 1574805

    Patients

    Seq Age Sex Outcome Treatment
    1 Female