BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANAL FINDING RASP RAT TAIL RASP

    MDR report key: 23390781 · Received October 27, 2025

    Report

    Report Number
    MW5177990
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Date of Event
    October 20, 2025
    Report Date
    October 21, 2025
    Manufacturer
    INNOMED, INC.
    Product Code
    GAC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING ANTERIOR HIP ARTHROPLASTY, THE TIP OF THE "RAT TAIL/CURVED RASP" INSTRUMENT BROKE OFF IN THE PATIENT'S FEMUR. BROKEN SECTION WAS REMOVED FROM THE FEMUR BY SURGEON AND VERIFIED THAT NO OTHER PIECES REMAINED. THE PROCEDURE WAS COMPLETED WITH NO INJURY TO THE PATIENT. X-RAY PERFORMED IN OPERATING ROOM CONFIRMED THAT BROKEN TIP PIECE WAS REMOVED ENTIRELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2351518 CANAL FINDING RASP RAT TAIL RASP RASP, SURGICAL, GENERAL & PLASTIC SURGERY GAC INNOMED, INC. (10)09221

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female