BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEPUY KINCISE IMPACTOR

    MDR report key: 19435973 · Received May 30, 2024

    Report

    Report Number
    MW5155641
    Event Type
    Other
    Date Received
    May 30, 2024
    Report Date
    May 28, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE KINCISE IMPACTOR FROM DEPUY IS TOO HARD TO CLEAN TO THE POINT IT IS DANGEROUS. IT IS ONLY HAND-WASHABLE, NOT SUBMERSIBLE, AND ALL ENCASED IS BLACK. IT IS CONSTANTLY BEING SENT BACK AFTER CLEANING DUE TO FINDING ADDITIONAL BLOOD ON IT, DESPITE GREAT EFFORTS FROM THE TECHNICIANS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148825 DEPUY KINCISE IMPACTOR INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE DEPUY ORTHOPAEDICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention