BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENSION DRUJ

    MDR report key: 2156032 · Received July 1, 2011

    Report

    Report Number
    1651501-2011-00052
    Event Type
    Injury
    Date Received
    July 1, 2011
    Date of Event
    June 1, 2011
    Report Date
    July 1, 2011
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    KXE
    PMA / PMN Number
    K052137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MFG RECORDS THAT WERE REVIEWED DID NOT IDENTIFY WHAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. THE INVESTIGATION IS ONGOING. IF ADD'L INFO IS COLLECTED/DETERMINED, A SUPPLEMENTAL REPORT WILL BE FILED AS APPROPRIATED.

    Description of Event or Problem · 1

    A DISTRIBUTOR REPORTED THAT A SURGEON HAD TROUBLE SEATING A DRUJ IMPLANT. THE SURGEON IDENTIFIED THE SIZE OF IMPLANT THEN STARTED TO IMPACT THE DEVICE AND PLACE IT INTO THE OSTEOTOMY. THE SURGEON REPORTED THAT HE WAS UNABLE TO SEAT THE IMPLANT. HE THEN SPENT 30 MINUTES TRYING TO REMOVE THE IMPLANT TO NO AVAIL. THE SURGEON MADE ONE LAST ATTEMPT TO SEAT THE IMPLANT AND THE ULNA FRACTURED. THE SURGEON CLOSED THE PT WITH THE DEVICE IN SITU, SURE THAT THE FRACTURE WOULD HEAL. THE DOCTOR STATED THAT THE PT HAS A GAP BETWEEN THE IMPLANT AND THE BONE WHICH HE BELIEVES IS CAUSING A CLICK DURING SUPINATION. HE ALSO STATED THAT HE BELIEVES THAT THE IMPLANT IN THE BOX WAS LARGER THAN WHAT WAS STATED ON THE BOX AND THAT THERE WAS A DIFFERENCE BETWEEN THE TRIAL STEM AND THE IMPLANT STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSION DRUJ WRIST JOINT ULNAR (HEMI-WRIST) PROSTHESIS KXE ASCENSION ORTHOPEDICS, INC. DRUJ-610-1755 10-2530

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention