BEUDAMED
    FDA Adverse Event Other Summary report: N

    MBARESORB

    MDR report key: 795216 · Received December 1, 2006

    Report

    Report Number
    2028840-2006-00023
    Event Type
    Other
    Date Received
    December 1, 2006
    Date of Event
    October 12, 2006
    Report Date
    November 30, 2006
    Manufacturer
    KINETIKOS MEDICAL, INC.
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IDENTIFYING THE ROOT CAUSE: THE INFO COLLECTED IN CONJUNCTION WITH THIS EVENT INCLUDED THE EVENT DATE, THE SUBJECT (MISSING) INSTRUMENT, THE ATTENDING PHYSICIANS NAME AND ADDRESS, AND THE VARIOUS ROOT CAUSE FACTORS THAT CONTRIBUTED TO IT. A DETAILED INVESTIGATION REVEALED MULTIPLE SYSTEMIC BREAKDOWNS WHICH ULTIMATELY RESULTED IN THIS EVENT, INCLUDING THE FOLLOWING: FOLLOWING THE RECENT TRANSFER OF SURGICAL INSTRUMENTATION INVENTORY FROM KINETIKOS MEDICAL, INC. TO THE INTEGRA CORPORATE DIST CENTER (RDC), THE SPECIFIC STOCK LOCATION OF EACH ITEM (INCLUDING ALL SURGICAL INSTRUMENTATION) COULD NOT BE ESTABLISHED WITH CONSISTENCY, WHICH WAS EXACERBATED BY THE INABILITY OF THE RDC PERSONNEL TO VISUALLY RECOGNIZE ALL OF KMI'S INSTRUMENTS. AS A RESULT OF THIS, THE INSTRUMENT NEEDED TO PERFORM THIS SURGERY (COMBO DRIVER 04-1040) WAS ASSUMED TO BE OUT OF STOCK AND WAS THEREFORE NOT SHIPPED WITH THE ORDER. AS TRAINING OF RDC PERSONNEL ON KMI PRODUCTS WAS STILL IN PROCESS, THE KNOWLEDGE THAT THE ABSENCE OF THIS INSTRUMENT WOULD PRECLUDE IMPLANTING AN MBARESORB IMPLANT HAD NOT BEEN ADEQUATELY IMPARTED TO THE RDC SHIPPING PERSONNEL WHO PROCEEDED TO FULFILL AND SHIP THE MBARESORB ORDER WITHOUT IT. THE SURGICAL WARD PERSONNEL HAD NOT TAKEN AN INVENTORY OF THE MBARESORB SHIPMENT AND/OR DID NOT RECOGNIZE THE CRUCIAL ABSENCE OF THE SUBJECT INSTRUMENT. THE KMI - INTEGRA SALES REP THAT WAS PRESENT HAD NOT TAKEN AN INVENTORY OF THE COMPLETE MBARESORB SHIPMENT AND/OR DID NOT RECOGNIZE THE CRUCIAL ABSENCE OF THE SUBJECT INSTRUMENT. THE ATTENDING PHYSICIAN HAD ASSUMED OR HAD BEEN ERRONEOUSLY INFORMED THAT ALL REQUIRED EQUIPMENT WAS PRESENT, AND THEREFORE PROCEEDED TO PREPARE THE PT FOR THE PLANNED IMPLANT SURGERY. CORRECTIVE/PREVENTATIVE ACTION. INTEGRA-KMI RDC PERSONNEL HAVE NOW BEEN TRAINED ON MBARESORB INSTRUMENT RECOGNITION AND THE NEED TO SHIP COMPLETE MBARESORB IMPLANT SETS TO ANY GIVEN SURGERY, INCLUDING ALL REQUIRED INSTRUMENTATION. A SYSTEM COMPONENTS LIST WHICH ITEMIZES ALL NEEDED SURGICAL INSTRUMENTS IS NOW IN USE FOR COMPILATION OF ORDERS. INTEGRA-KMI SALES REPS HAVE NOW BEEN TRAINED ON THE NEED TO INVENTORY BOTH IMPLANTS AND INSTRUMENTATION PRIOR TO EACH SURGERY THEY ATTEND TO ENSURE ALL NECESSARY EQUIPMENT IS PRESENT. A SYSTEM COMPONENTS LIST WHICH ITEMIZES ALL NEEDED SURGICAL INSTRUMENTS IS NOW PROVIDED WITH EACH INSTRUMENT ORDER SHIPPED. NO INFO HAS BEEN OBTAINED AS TO ACTIONS OR TRAINING THAT HAS TAKEN PLACE AT HOSP.

    Description of Event or Problem · 1

    ON 10/31/06, KINETIKOS MEDICAL, INC., WAS INFORMED THAT THE PLANNED IMPLANTING OF A MBARESORB HAD TO BE DEFERRED AFTER IT WAS DISCOVERED THAT A VITAL SURGICAL INSTRUMENT WAS MISSING FROM THE SHIPMENT. THIS DISCOVERY WAS MADE AFTER THE PT'S SURGICAL SITE HAD BEEN OPENED IN PREPARATION FOR SURGERY, AND NECESSITATED THAT THE SITE BE CLOSED WITHOUT THE DEVICE BEING IMPLANTED. ON 10/31/06, KINETIKO'S MEDICAL, INC., WAS INFORMED THAT THE PLANNED IMPLANTING OF A MBARESORB HAD TO BE DEFERRED AFTER IT WAS DISCOVERED THAT A VITAL SURGICAL INSTRUMENT WAS MISSING FROM THE SHIPMENT. THIS DISCOVERY WAS MADE AFTER THE PT'S SURGICAL SITE HAD BEEN OPENED IN PREPARATION FOR SURGERY, AND NECESSITATED THAT THE SITE BE CLOSED WITHOUT THE DEVICE BEING IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MBARESORB ORTHOPEDIC FOOT IMPLANT HRS KINETIKOS MEDICAL, INC. 04-01XX NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Hospitalization