BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR REAMER HEAD

    MDR report key: 11776150 · Received May 5, 2021

    Report

    Report Number
    11776150
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Date of Event
    April 22, 2021
    Report Date
    April 28, 2021
    Manufacturer
    BIOMET ORTHOPEDICS, LLC
    Product Code
    HTO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PIECE OF REAMER BROKE OFF IN PATIENT, LEFT IN HIM (2MM IN SIZE). DURING THE GAMMA NAIL REPAIR FOR HIP FX (FRACTURE), A FLEXIBLE REAMER BROKE. MOST OF THE REAMER HEAD WAS REMOVED, A 1 - 2MM PIECE OF THE REAMER HEAD IS IN THE INTRAMEDULLARY CANAL. THE RISKS OUTWEIGH THE BENEFIT OF REMOVAL OF THE BROKEN PIECE OF REAMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671845 MODULAR REAMER HEAD REAMER HTO BIOMET ORTHOPEDICS, LLC 2810-04-110 EW9AN4

    Patients

    Seq Age Sex Outcome Treatment
    1 28105 DA