BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 2193102 · Received July 21, 2011

    Report

    Report Number
    2523190-2011-00051
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Report Date
    July 21, 2011
    Manufacturer
    UNK
    Product Code
    GES
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    DR (B)(6), ORTHOPEDIC SURGEON AT (B)(6) LEFT MESSAGE FOR INTEGRA-SURGICAL REP THAT OUR BLADE HANDLE WAS NOT AFFIXED TIGHTLY TO THE KNIFE BLADE DURING SURGERY PERFORMED IN (B)(6) 2011. IT WAS NOT REALIZED THAT THE KNIFE BLADE WAS LEFT IN THE PT SHOULDER UNTIL PT CAME IN FOR A SECOND SURGERY ON (B)(6) 2011 AND THE KNIFE BLADE WAS REMOVED FROM THE SHOULDER. KNIFE BLADE IS A DISPOSABLE ITEM AND WAS DISCARDED AFTER BEING REMOVED FROM THE SHOULDER. INTEGRA SURGICAL REP IMMEDIATELY CALLED (B)(6) TO GET ALL THE DETAILS. PER (B)(6), SHE CANNOT CONFIRM THIS IS AN INTEGRA PRODUCT BECAUSE THEY PURCHASE BLADE HANDLES FROM DIFFERENT SUPPLIERS. SHE STATED TO (B)(6) THAT THEY ARE UNABLE TO CONFIRM WHAT SURGICAL TRAY THE INSTRUMENT WAS FROM. INTEGRA SURGICAL REP WAS INFORMED A LAWSUIT IS PENDING. ON (B)(6) 2011, (B)(6) REPORTED TO ME VIA PHONE TODAY THAT THE PROCEDURE WAS AN ARTHROSCOPY PERHAPS FOR A ROTATOR CUFF. THE KNIFE HANDLE WAS A SIZE #3, AND THE DISPOSABLE KNIFE BLADE WAS A SIZE #11, NEITHER ARE AVAILABLE FOR INVESTIGATION. SHE STATED THERE WAS A SECOND SURGERY TO REMOVE THE DISPOSABLE KNIFE BLADE. THE BLADE WAS FOUND UNDER THE SURFACE OF THE SKIN, NOT IN THE SHOULDER. PRIOR TO THIS DISCOVERY, THE PT HAD BEEN COMPLAINING OF "FEELING SOMETHING UNDER THE SKIN." THERE WAS NO SUBSEQUENT HARM/DAMAGE REPORTED ACCORDING TO (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE GES UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention