BEUDAMED
    FDA Adverse Event Summary report: N

    DEPUY MITEK INC OMNISPAN MENISCAL REPAIR SYSTEM

    MDR report key: 3660070 · Received March 5, 2014

    Report

    Report Number
    3002719998-2014-00002
    Date Received
    March 5, 2014
    Date of Event
    April 16, 2013
    Report Date
    January 21, 2014
    Manufacturer
    RTI SURGICAL INC
    Product Code
    NEW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE INFO: ARTHREX ACL TIGHTROPE RT, DEPUY MITEK BIO-INTRAFIX TAPERED SCREW 7-9MM X 30MM AND DEPUY MITEK BIO-INTRAFIX TIBIAL SHEATH, LARGE. DONOR AND MANUFACTURING RECORDS WERE RE-REVIEWED AS PART OF RTI'S INVESTIGATION. THERE WERE NO DEVIATIONS NOTED FOR DONOR (B)(6). PRE-PROCESSING CULTURES FROM DONOR (B)(6) WERE NEGATIVE FOR GROWTH EXCEPT FOR 3 BONE TISSUES AND 1 SOFT TISSUE. THE MICROORGANISMS IDENTIFIED ARE ACCEPTABLE TO BE PRESENT ON TISSUES PRIOR TO PROCESSING BASED ON RTI'S STERILIZATION VALIDATION. ENVIRONMENTAL MONITORING RESULTS FOR THE WEEK PRIOR, DURING, AND THE WEEK FOLLOWING PROCESSING EPISODES FOR DONOR (B)(6) WITH A SURFACE ACTION LEVEL IN ROOM 2 ON (B)(6) 2011 (7 DAYS PRIOR TO SOFT TISSUE PROCESSING FOR THE DONOR). THE MICROORGANISM IDENTIFIED WAS GRAM NEGATIVE ROD. THE FOLLOWING ACTIONS WERE PERFORMED; CLEANING LOGS WERE REVIEWED WITH NO DEVIATIONS NOTED; SURFACE RESULTS FROM 5 PROCESSING DAYS PRIOR TO AND 5 PROCESSING DAYS AFTER THE EXCURSION WERE REVIEWED WITH NO TREND IDENTIFIED; AND VIABLE AIR AND WATER RESULTS FROM THE AREA WERE REVIEWED AND WERE WITHIN ACCEPTABLE LIMITS. ALL OTHER ENVIRONMENTAL DATA FROM PROCESSING AREAS WERE REVIEWED DURING AND AROUND THE TIME OF PROCESSING OF THE DONOR'S TISSUE WAS ACCEPTABLE AND WITHOUT EXCURSION NOTED. REVIEW OF ENVIRONMENTAL DATA AND RECORDS GENERATED DURING AND AROUND THE TIME OF PROCESSING OF SOFT TISSUE ALLOGRAFTS ASSOCIATED WITH DONOR (B)(6) DO NOT DOCUMENT NEGATIVE IMPACT OR CONTAMINATION OF THE ALLOGRAFTS. GRAFT ID 8195464 UNDERWENT A VALIDATED STERILIZATION METHODOLOGY; BIOCLEANSE. THE 14-DAY STERILITY SWAB AND DESTRUCTIVE POST-PROCESSING CULTURE RESULTS WERE NEGATIVE FOR GROWTH. REVIEW OF STERILITY CULTURE RESULTS OBTAINED FROM OTHER DONOR TISSUES ASEPTICALLY PACKAGED IN THE SAME AREA FROM (B)(6) 2011. RESULTS INDICATED 1 SWAB OBTAINED 4 DAYS AND 23 DONORS PRIOR, SO ASEPTIC PACKAGING OF DONOR (B)(6) WAS POSITIVE FOR GROWTH. THE MICROORGANISM IDENTIFIED WAS CNS. THREE SWAB CULTURES OBTAINED 6 DAYS AND 15 DONORS AFTER ASEPTIC PACKAGING OF DONOR (B)(6) WERE POSITIVE FOR GROWTH. THE MICROORGANISM IDENTIFIED WAS YEAST. ONE SPECIMEN AND 11 SWABS OBTAINED 7 DAYS AND 18 DONORS AFTER ASEPTIC PACKAGING OF DONOR (B)(6) WERE POSITIVE FOR GROWTH. THE MICROORGANISM IDENTIFIED WAS YEAST. ONE SPECIMEN AND 7 SWABS OBTAINED 7 DAYS AND 19 DONORS AFTER ASEPTIC PACKAGING OF DONOR (B)(6) WAS POSITIVE FOR GROWTH. THE MICROORGANISM IDENTIFIED WAS YEAST. TO DATE, RTI HAS MFG AND DISTRIBUTED (B)(4) ALLOGRAFTS FROM DONOR (B)(6) AND RECEIVED (B)(4) RECORDS OF IMPLANTATION. REVIEW OF RECOVERY RECORDS SHOW THAT CORNEAS, CARDIO AND VASCULAR TISSUES, AND MUSCULOSKELETAL TISSUES WERE RECOVERED BY AN INDEPENDENTLY REGISTERED EYE/TISSUE BANK. RTI RECEIVED ALL MUSCULOSKELETAL TISSUES FROM THE DONOR FOR THE PURPOSE OF IMPLANTATION. THERE ARE NO RELATED COMPLAINTS ASSOCIATED WITH THE CORNEAS OR CARDIO AND VASCULAR TISSUES FROM THE DONOR. THERE ARE NO RELATED COMPLAINTS ASSOCIATED WITH THE RTI DISTRIBUTED MUSCULOSKELETAL ALLOGRAFTS FROM THE DONOR. TO DATE, RTI'S INVESTIGATION IS WITHOUT INDICATION THAT THE ALLOGRAFT CONTRIBUTED TO COMMUNICABLE TRANSMISSION.

    Description of Event or Problem · 1

    ON (B)(4) 2014, RTI SURGICAL, INC (RTI) WAS INFORMED OF A COMPLAINT INDICATING THE PT DEVELOPED A POST-OPERATIVE INFECTION. CLINICAL RECORDS INDICATED THE PT UNDERWENT A LEFT ACL AND LATERAL MENISCUS REPAIR ON (B)(6) 2013. ON (B)(6) 2013, THE PT RETURNED FOR FOLLOW-UP WITH PAIN. UPON EXAMINATION, MINOR EFFUSION WAS NOTED TO BE PRESENT ABOVE THE ANTERIOR SUPERIOR ASPECT OF THE KNEE WITH NO ECCHYMOSIS OR INFECTION NOTED. ON (B)(6) 2013, THE PT RETURNED FOR F/U WITH INCREASED REDNESS AND PAIN OVER THE ANTERIOR TIBIAL INCISION WITH YELLOW AND RED DRAINAGE. UPON EXAMINATION, THE KNEE WAS ASPIRATED AND A VERY SMALL AMOUNT OF SEROSANGUINEOUS FLUID WITH BLOOD TINGE WAS OBTAINED. MEDICAL RECORD DOCUMENTED THE PT SYMPTOMS COULD BE SUPERFICIAL CELLULITIS CAUSED FROM A QUESTIONABLE SUTURE ABSCESS ALONG THE SUPERIOR ASPECT OF THE INCISION. THE PT ADMITTED TO APPLYING NEOSPORIN ON THE WOUND AGAINST POST-OP INSTRUCTIONS. FINAL WOUND CULTURES WERE NEGATIVE FOR GROWTH. ANTIMICROBIAL THERAPY WAS INITIATED. ON (B)(6) 2013, THE PT RETURNED FOR F/U. THE PT STATED THE SWELLING WAS ALMOST GONE AND THE DRAINAGE WAS MINIMAL. UPON EXAMINATION, A LITTLE DRAINAGE AND MINIMAL ERYTHEMA WERE NOTED. MEDICAL RECORDS DOCUMENTED THAT THE CULTURES FROM (B)(6) 2013 WERE NEGATIVE. THE PT'S WHITE COUNT, SEDIMENTATION RATE, AND CRP WAS NORMAL. MEDICAL RECORD ALSO DOCUMENTED THE PT'S SYMPTOMS WERE LIKELY DUE TO A STERILE SUTURE ABSCESS OR POSSIBLY EVEN JOINT FLUID COMING DOWN THROUGH THE BONE TUNNEL CAUSING SUPERFICIAL IRRITATION. ON (B)(6) 2013, THE PT RETURNED FOR FOLLOW-UP INDICATING ON (B)(6) 2013, HE NOTICED INCREASED REDNESS AROUND THE INCISION SITE THAT WAS TENDER TO THE TOUCH. UPON EXAMINATION, NO ERYTHEMA, SOFT TISSUE SWELLING, OR TENDERNESS TO PALPATION WAS NOTED. ON (B)(6) 2013, THE PT UNDERWENT AN ARTHROSCOPIC DEBRIDEMENT, SYNOVECTOMY, ANTIBIOTIC IRRIGATION, AND OPEN DEBRIDEMENT OF THE TIBIAL TUNNEL. DURING THE PROCEDURE, IT WAS NOTED THAT THE TIBIAL HARDWARE WAS LOOSE AND WAS EXPLANTED. NO PURULENT MATERIAL WAS OBSERVED. THE ALLOGRAFT REMAINS IMPLANTED. FINAL FLUID CULTURE RESULTS WERE NEGATIVE FOR GROWTH. PATHOLOGY REPORT OF THE KNEE SHAVINGS INDICATED ACUTE INFLAMMATORY EXUDATE CONSISTENT WITH ACUTE ARTHRITIS. FINAL TISSUE FUNGUS RESULTS WERE NEGATIVE FOR GROWTH. FINAL GRAM STAIN CULTURE RESULTS FOR THE EXPLANTED SCREWS WAS POSITIVE FOR GRAM POSITIVE BACILLI AND RARE GRAM POSITIVE COCCI AND THE FINAL CULTURE RESULTS WERE NEGATIVE FOR GROWTH. FINAL ANAEROBIC CULTURE RESULT FOR THE EXPLANTED SCREWS YIELDED MODERATE PROPIONIBACTERIUM ACNES. ON (B)(6) 2013, THE PT RETURNED FOR FOLLOW-UP. UPON EXAMINATION, IT WAS NOTED THAT THE EFFUSION HAD DECREASED AND NO ERYTHEMA WAS OBSERVED. AT THE LAST FOLLOW-UP VISIT ((B)(6) 2013), UPON EXAMINATION, NO SWELLING, EDEMA, OR ERYTHEMA OF SURROUNDING TISSUE WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133527 DEPUY MITEK INC OMNISPAN MENISCAL REPAIR SYSTEM OMNISPAN MENISCAL REPAIR SYSTEM NEW RTI SURGICAL INC

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other