BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT: NAIL

    MDR report key: 9241795 · Received October 25, 2019

    Report

    Report Number
    3025141-2019-00417
    Event Type
    Malfunction
    Date Received
    October 25, 2019
    Report Date
    September 26, 2019
    Manufacturer
    ACUMED LLC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL CASES ASSOCIATED WITH THIS ARTICLE: 3025141-2019-00414: CASE 1, 3025141-2019-00415: CASE 2, 3025141-2019-00416: CASE 3.

    Description of Event or Problem · 1

    ARTICLE: TREATMENT OF PROXIMAL HUMERAL FRACTURES WITH POLARUS NAIL FIXATION NAIL, AGEL, JULIE, MA; JONES, CLIFFORD B, MD; SANZONE, ANTHONY G., MD; CAMUSO, MATTHEW, MD; HENLEY, M. BRADFORD, MD; JOURNAL OF SHOULDER AND ELBOW SURGERY, 2004, VOLUME 13, NUMBER 2, 191-195. CASE 4: PATIENT HAD A PROXIMAL SCREW THAT PENETRATED THE ARTICULAR SURFACE, FOLLOWING IMPLANTATION OF A POALRUS NAIL. THE NAIL WAS LOCKED PROXIMALLY ABOVE THE OSSEOUS SURFACE, WHICH POTENTIALLY CREATED THE SUBACROMIAL IRRITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037178 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT: NAIL LXH ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1