BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUOHEX CH CANNULATED HAMMERTOE SYSTEM

    MDR report key: 11727389 · Received April 26, 2021

    Report

    Report Number
    3009540749-2021-00012
    Event Type
    Malfunction
    Date Received
    April 26, 2021
    Date of Event
    April 5, 2021
    Report Date
    April 26, 2021
    Manufacturer
    NEXTREMITY SOLUTIONS
    Product Code
    HWC
    PMA / PMN Number
    K200840
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    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

    DURING A BETA SURGERY USING THE NEXTRA CH HAMMERTOE SYSTEM ON (B)(6) 2021 THE FOLLOWING WAS REPORTED: THE REAMER ON THE MIDDLE PHALANX COLLAPSED, POTENTIALLY AS A RESULT OF TOO MUCH BONE BEING RESECTED. THE MIDDLE PHALANX WAS ESSENTIALLY PINNED THROUGH THE PROXIMAL IMPLANT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622222 DUOHEX CH CANNULATED HAMMERTOE SYSTEM SCREW HWC NEXTREMITY SOLUTIONS 1574809

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR