BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION EXTERNAL PLATING SYSTEM

    MDR report key: 13082780 · Received December 23, 2021

    Report

    Report Number
    3015536247-2020-00008
    Event Type
    Malfunction
    Date Received
    December 23, 2021
    Date of Event
    April 17, 2020
    Report Date
    December 23, 2020
    Manufacturer
    NEW STANDARD DEVICE INC.
    Product Code
    KTT
    PMA / PMN Number
    K053472
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION IS OMITTED FROM THIS REPORT AS IT WAS NOT AVAILABLE AT THE TIME THE REPORT WAS SUBMITTED: PATIENT GENDER, PATIENT WEIGHT, ETHNICITY, RACE, RELEVANT TESTS/LABORATORY DATA, CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES, LOT #, EXPLANT DATE, DEVICE MFR DATE, REMOVAL ACTION #. AN ATTEMPT WAS MADE TO OBTAIN ADDITIONAL INFORMATION: IN A PHONE CONVERSATION WITH THE SALES REPRESENTATIVE HE STATED HE DID NOT HAVE ANY ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    DR. (B)(6) HAD A 1.8MM TRUSS WIRE BREAK DURING A SURGERY AT (B)(4) HOSPITAL ON (B)(6) 2020. POSTING BY SURGEON ON (B)(4): "SURGERY PERFORMED BY DR. (B)(6), PREVIOUS TTC WITH NAIL/EX-FIX THAT BECAME INFECTED. DR. HOLMES REMOVED THE NAIL, PLACED AN ANTIBIOTIC NAIL, AND ADDED THE REVOLUTION EXTERNAL FIXATION SYSTEM TO COMPRESS THROUGH THE NAIL USING THREE HALF-RINGS TO THE TIBIA. DISTAL RING WAS FLIPPED 180 DEGREES TO MATCH UP WITH THE FOOT PLATE, ALLOWING HIM TO COMPRESS ACROSS THE ANKLE JOINT WITH THREE BOLTS." FIELD REP. STATED THAT "I WAS IN THE CASE I DON'T RECALL A WIRE BREAKING DURING SURGERY ON (B)(6) 2020. WE DID REMOVE TWO WIRES SO WE CAN ASSEMBLE THE FOREFOOT BRIDGE. THE FRAME WAS TENSION BEFORE AND THEN WE TRIED TO ASSEMBLE THE BRIDGE. AT THAT TIME WE HAD TO REMOVE TWO WIRES. WHEN WE REMOVED AN ANKLE FUSION NAIL. THERE WAS A PIECE OF A 1.8 WIRE THAT WAS BROKEN FROM THE ORIGINAL SURGERY AND HAD TO BE REMOVED AS THE PATIENT HAD A BAD INFECTION. IT WAS NEAR THE TOP OF ANKLE FUSION NAIL. A 2-3 CM PIECE OF A WIRE WAS BROKEN FROM THE ORIGINAL SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1969837 REVOLUTION EXTERNAL PLATING SYSTEM SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCES AND ACCESSORIES KTT NEW STANDARD DEVICE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown EXTERNAL FIXATION SYSTEM - NOT A METALOGIX PRODUCT