BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1812-15 AIM SUPRACONDYLAR NAIL

    MDR report key: 173063 · Received June 15, 1998

    Report

    Report Number
    2020311-1998-00006
    Event Type
    Malfunction
    Date Received
    June 15, 1998
    Date of Event
    May 17, 1998
    Report Date
    May 18, 1998
    Manufacturer
    DEPUY ACE MEDICAL CO
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BROKE AT SECOND DISTAL SCREW HOLE. BROKE WHILE WALKING. SUSTAINED A SUPRACONDYLAR FRACTURE AND AN INTRACONDYLAR FRACTURE. SUPRACONDYLAR FRACTURE HAD A NON-UNION. PT WAS VERY COMPLIANT-BREAKAGE OCCURRED 8-9 MONTHS POST-OP. SURGEON FEELS HE MAY HAVE NOTCHED THE NAIL WITH THE LOCKING SCREWS. REMOVED WITH EXTRACTION INSTRUMENTS. REPLACED WITH SUPRACONDYLAR PLATE WITH 8 HOLES. 3 WEEKS POST-OP, LOOKS VERY GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1812-15 AIM SUPRACONDYLAR NAIL Implant INTRAMEDULLARY ROD HSB DEPUY ACE MEDICAL CO NA F4919

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR CANCELLOUS SCREWS.| INTRACONDYLAR FRACTURE, HAS HEALED WITH 6.5MM