BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIFIT TS

    MDR report key: 25093096 · Received May 6, 2026

    Report

    Report Number
    9614209-2026-00055
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    April 16, 2026
    Report Date
    May 6, 2026
    Manufacturer
    CORIN LTD
    Product Code
    KWY
    UDI-DI
    05055343884171
    PMA / PMN Number
    K121563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PER (B)(4). INITIAL REPORT: ADDITIONAL INFORMATION INCLUDING: CONFIRMATION OF THE DEVICE LOT CODE. WHAT DEVICE WAS BEING USED ALONGSIDE THE RASP WHEN THE SPIGOT BROKE. HOW WAS THE RASP EVENTUALLY EXTRACTED FROM THE FEMORAL CANAL? WAS THE REST OF THE SURGERY CARRIED OUT AS PLANNED? HAS BEEN REQUESTED. THE REPORTER CONFIRMED THAT THE FEMUR WAS BROKEN IN ORDER TO REMOVE THE RASP, HOWEVER, THE DEVICE LOT CODES HAVE NOT YET BEEN RECEIVED. UPON RECEIPT OF THE DEVICE LOT CODES THE RELEVANT DEVICE MANUFACTURING RECORDS WILL BE IDENTIFIED AND REVIEWED. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURED OUTSIDE OF THE USA. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    TRIFIT TS RASP SPIGOT BROKE DURING SURGERY. THE PROCEDURE WAS DELAYED AND THE FEMUR CUT TO REMOVE THE RASP

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595889 TRIFIT TS TRIFIT TS HIP STEM (RASP) KWY CORIN LTD 695.104 TBC 05055343884171

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown