BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNGER CANAL FINDER RASP CURVED

    MDR report key: 19442052 · Received June 1, 2024

    Report

    Report Number
    1833053-2024-00002
    Event Type
    Malfunction
    Date Received
    June 1, 2024
    Date of Event
    April 1, 2024
    Report Date
    May 21, 2024
    Manufacturer
    INNOMED, INC.
    Product Code
    GAC
    UDI-DI
    00840277104960
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL REPORTER IS NOT IDENTIFIED, AND THERE IS NO CONTACT INFORMATION AVAILABLE TO SEND A REQUEST FOR RETURN OF THE DEVICE FOR INSPECTION AND EVALUATION. THE USER FACILTY IS ALSO NOT LISTED. THE INTERNAL COMPLAINTS AND CAPA DATABASES WILL BE SURVEYED FOR SIMILAR ISSUES ASSOCIATED WITH THE REFERENCED DEVICE. A SUMMARY WILL BE INCLUDED IN THE FOLLOW UP REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT RASP BECAME STUCK IN FEMUR. SURGEON APPLIED MORE FORCE AND THE HANDLE SEPARATED FROM RASP. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION. PROCEDURE: TOTAL HIP REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308513 UNGER CANAL FINDER RASP CURVED RASP, SURGICAL, GENERAL & PLASTIC SURGERY GAC INNOMED, INC. 3004-01 00840277104960

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown