BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX

    MDR report key: 10665231 · Received October 12, 2020

    Report

    Report Number
    3007289093-2020-00019
    Event Type
    Malfunction
    Date Received
    October 12, 2020
    Date of Event
    September 3, 2020
    Report Date
    October 12, 2020
    Manufacturer
    EXTREMITY MEDICAL, LLC.
    Product Code
    HWC
    PMA / PMN Number
    K130120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT THE 2.0 HEX DRIVER DEFORMED AND THEN BROKE DURING INSERTION OF APEX POSTS. INSERTION OF THE POST WAS REALLY TIGHT. THE SURGEON WAS ABLE TO GET THE POST IN THE MIDDLE FINGER PIP JOINT BUT NOTICED THAT THE DRIVER WAS TWISTED. DURING INSERTION OF ANOTHER POST IN THE INDEX FINGER PIP, THE POST HAD ABOUT 5-6 MM TO GO AND THE SURGEON FELT IT WAS REALLY TIGHT, AND THE DRIVER BROKE. THE SURGEON THEN TRIED USING PLIERS TO REMOVE THE POST AND THE HEAD OF THE POST BROKE OFF. THE SURGEON WAS UNABLE TO REMOVE THE TIP OF THE POST, AND WAS ABLE TO COMPLETE THE CASE BY PLATING OVER THE TOP DORSALLY WITH A PLATE AND 6 SCREWS (3 SCREWS ON EITHER SIDE OF THE JOINT). THE POST THAT BROKE WAS A 4.0 X 20 MM POST X 30 DEG. THE SURGEON INDICATED THE PATIENT HAD HARD, DENSE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131490 APEX BONE SCREW HWC EXTREMITY MEDICAL, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1