BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTAL RADIOULNAR JOINT ASSEMBLY

    MDR report key: 2518311 · Received March 16, 2009

    Report

    Report Number
    3004521401-2009-00002
    Event Type
    Injury
    Date Received
    March 16, 2009
    Date of Event
    February 17, 2009
    Report Date
    March 13, 2009
    Manufacturer
    APTIS MEDICAL, LLC.
    Product Code
    KXE
    PMA / PMN Number
    K040497
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER RECEIVING THE SCREWS, THEY WERE VISUALLY INSPECTED FOR DEFECTS INCLUDING STRIPPED THREADS AND/OR STRIPPED HEADS. BOTH SCREWS WERE UNDAMAGED AND FUNCTIONED AS DESIGNED WHEN APPLIED TO TEST PIECES. FACTORS POSSIBLY ALLOWING THE LOOSENING OF THE SCREW INCLUDE, ANATOMY INTERPOSED BETWEEN THE MATING SURFACES OF THE DEVICE DURING ASSEMBLY. INSUFFICIENT TIGHTENED OF THE SCREWS DURING INITIAL ASSEMBLY. STRESS EXCEEDING RECOMMENDATIONS DURING USE OF THE DEVICE. THE PT IS AN AVID GOLFER AND WAS INFORMED PRIOR TO INITIAL IMPLANTATION OF THE DEVICE THAT CARE SHOULD BE TAKEN TO LIMIT STRESSES ON THE DEVICE. THE PT ADMITTED TO THE SURGEON, GOLFING ON A FREQUENT BASIS AND HIGH FORCE GROUND STRIKES DURING PLAY. THE KNOWN INCIDENCE OF OCCURRENCE AT THIS TIME IS LESS THE 1% OF IMPLANTED DEVICES, THE POSSIBLE FACTORS WILL BE DISCUSSED WITH USING PHYSICIANS AND CONTINUED MONITORING WILL PROCEED.

    Description of Event or Problem · 1

    TWO SMALL SCREWS WHICH COMPRISE PARTS OF A DISTAL RADIOULNAR JOINT PROSTHESIS LOOSENED FROM THEIR ASSEMBLED POSITION INSIDE THE DISTAL FOREARM OF A PT. THIS REQUIRED A RE-OPERATION TO REASSEMBLE THE DEVICE. THE SCREWS WERE INSPECTED BY THE SURGEON DURING THE PROCEDURE AND FOUND TO BE FUNCTIONING AS INTENDED. TO ALLOW FURTHER INSPECTION OF THE SCREWS, THEY WERE REPLACED AND THE DEVICE WAS REASSEMBLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISTAL RADIOULNAR JOINT ASSEMBLY KXE APTIS MEDICAL, LLC. DRUJ-P30 K08520

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention