BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BROKEN 2.7 CO TREPHINE

    MDR report key: 14189740 · Received April 22, 2022

    Report

    Report Number
    3025141-2022-00094
    Event Type
    Malfunction
    Date Received
    April 22, 2022
    Date of Event
    March 17, 2022
    Report Date
    April 18, 2022
    Manufacturer
    ACUMED, LLC
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND. THE RETURNED PRODUCTS WERE INSPECTED UNDER MAGNIFICATION. UNDER MAGNIFICATION, THE BATCH NUMBER FOR THE TWO BROKEN 2.7 CO TREPHINES (P/N 80-0217) WAS CONFIRMED AS 455805. THE RETURNED TREPHINES SHOWED MINIMAL SIGNS OF DAMAGE ALONG THE SHAFTS. NEITHER INDICATED SIGNS OF SIGNIFICANT USAGE. ONE OF THE BROKEN 2.7 CO TREPHINES SHOWED A SMALL LINE OF WORN METAL CLOSE TO THE TEETH OF THE TREPHINE AND BOTH PRODUCTS SHOWED SLIGHT, MINIMAL DENTING AND DEFORMATION ON SOME OF THE TEETH. THE SLIGHT WEAR SHOWN ON THE TEETH IS INDICATIVE OF THE TREPHINES BEING DULL AND WORN PRIMARILY IN THE CUTTING AREA WHICH CAN GREATLY AFFECT THEIR ABILITY TO REMOVE SCREWS FROM PLATES AND BONE. THE SCREWS AND PLATE USED WITH THESE PRODUCTS WERE NOT RETURNED. NO DEFINITIVE CONCLUSION CAN BE MADE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE REMOVAL INSTRUMENTS FAILED TO REMOVE THE SCREWS FROM THE PLATE AND FROM THE BONE AFTER THE PLATE WAS REMOVED. COMPETITOR DEVICES WERE NEEDED TO SUCCESSFULLY REMOVE THE HARDWARE. THIS ISSUE RESULTED IN THE PROCEDURE TAKING A FEW HOURS. THIS REPORT IS RELATED TO REPORT NUMBERS: 3025141-2022-00093, 3025141-2022-00095, 3025141-2022-00096, 3025141-2022-00097, 3025141-2022-00098, 3025141-2022-00099, 3025141-2022-00100, 3025141-2022-00101, 3025141-2022-00102, AND 3025141-2022-00103 FOR THE OTHER DEVICES INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953432 BROKEN 2.7 CO TREPHINE BIT, DRILL HTW ACUMED, LLC 80-0217 455805

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown