BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURVED CANAL FINDERMANUAL SURGICAL INSTRUMENT FOR GENERAL USE

    MDR report key: 16713518 · Received April 11, 2023

    Report

    Report Number
    3004776227-2023-02341
    Event Type
    Malfunction
    Date Received
    April 11, 2023
    Date of Event
    December 28, 2021
    Report Date
    March 31, 2023
    Manufacturer
    SYMMETRY MEDICAL MANUFACTURING, INC
    Product Code
    HTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DURING AN ANTERIOR PRIMARY HIP REPLACEMENT, DR. USED THE KYOCERA LATERALIZING RASP TO HELP GAIN ENTRY INTO THE FEMORAL CANAL. HE THEN BEGAN BROACHING AND TOOK AN X-RAY. HE NOTICED THE TIP OF THE RASP HAD BROKEN OFF INSIDE THE PATIENT. HE ATTEMPTED TO EXTRACT IT SEVERAL TIMES BUT WAS UNSUCCESSFUL. THE RASP DURING AN ANTERIOR PRIMARY HIP REPLACEMENT, DR. USED THE KYOCERA LATERALIZING RASP TO HELP GAIN ENTRY INTO THE FEMORAL CANAL. HE THEN BEGAN BROACHING AND TOOK AN X-RAY. HE NOTICED THE TIP OF THE RASP HAD BROKEN OFF INSIDE THE PATIENT. HE ATTEMPTED TO EXTRACT IT SEVERAL TIMES BUT WAS UNSUCCESSFUL. THE RASP WAS TAKEN BY THE SURGERY CENTER STAFF TO CLEAN AND EXAMINE FURTHER. AS TAKEN BY THE SURGERY CENTER STAFF TO CLEAN AND EXAMINE FURTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425212 CURVED CANAL FINDERMANUAL SURGICAL INSTRUMENT FOR GENERAL USE RASP HTR SYMMETRY MEDICAL MANUFACTURING, INC 10-255-000-SMB 7961401

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown