BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACUFEX

    MDR report key: 85359 · Received July 2, 1996

    Report

    Report Number
    85359
    Event Type
    Other
    Date Received
    July 2, 1996
    Date of Event
    March 8, 1996
    Report Date
    April 11, 1996
    Manufacturer
    ACUFEX MICROSURGICAL, INC.(SMITH & NEPHEW)
    Product Code
    HRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    METAL PIN WAS LOADED IN DRILL WHILE BEING USED ON PT'S KNEE. PIN BROKE INTO 2 PIECES WITH ONE REMAINING IN THE PT'S KNEE. (APPROX 2")

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUFEX ACL PASSING PIN 2.4MM HRX ACUFEX MICROSURGICAL, INC.(SMITH & NEPHEW) * *

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other