BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUFEX DRILL TIP GUIDE WIRE

    MDR report key: 92617 · Received May 19, 1997

    Report

    Report Number
    92617
    Event Type
    Malfunction
    Date Received
    May 19, 1997
    Date of Event
    April 16, 1997
    Report Date
    April 18, 1997
    Manufacturer
    ACUFEX MICROSURGICAL INC.
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE GUIDEWIRE BEING USED IN THE FEMORAL TUNNEL BROKE DURING AN ACL REPAIR. 4 CM WERE RETAINED IN THE FEMORAL TUNNEL (RIGHT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUFEX DRILL TIP GUIDE WIRE GUIDEWIRE FOR ACL REPAIR HRX ACUFEX MICROSURGICAL INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other