BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 9337442 · Received November 18, 2019

    Report

    Report Number
    2210968-2019-90057
    Event Type
    Injury
    Date Received
    November 18, 2019
    Report Date
    October 25, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. CITATION: THE JOURNAL OF ARTHROSCOPIC AND RELATED SURGERY (2008); 24(7): PP 779-785. DOI: 10.1016/J. ARTHRO. 2008.02.008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: MENISCAL REPAIR USING AN ALL-INSIDE, RAPIDLY ABSORBING, TENSIONABLE DEVICE". AUTHOR : MARK J. BILLANTE, M.D., DAVID R. DIDUCH, M.D., DAVID J. LUNARDINI, GEHRON P. TREME, IM.D. MARK D. MILLER, M.D., AND JOSEPH M. HART, PH.D., A.T.C. CITATION: THE JOURNAL OF ARTHROSCOPIC AND RELATED SURGERY (2008); 24(7): PP 779-785. DOI: 10.1016/J. ARTHRO. 2008.02.008. THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE CLINICAL SUCCESS RATE OF ALL-INSIDE MENISCAL REPAIRS USING A RAPIDLY ABSORBING DEVICE IN PATIENTS UNDERGOING CONCURRENT ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTIONS. PATIENTS WITH MENISCI REPAIRED USING THE POLYDIOXANONE MITEK RAPIDLOC (DEPUY MITEK) DURING CONCURRENT ACL RECONSTRUCTION BETWEEN JULY 2003 AND AUGUST 2005 WERE EVALUATED CLINICALLY 2 YEARS FOLLOWING INDEX SURGERY. EXAMINATIONS WERE PERFORMED ON 38 MENISCAL TEARS (18 IN MALE AND 20 IN FEMALE) IN 30 PATIENTS USING THE INTERNATIONAL KNEE DOCUMENTATION COMMITTEE FORM AND THE KNEE DISORDERS SUBJECTIVE HISTORY VISUAL ANALOG SCALE. ALL MENISCAL REPAIRS WERE PERFORMED WITH THE PDS RAPIDLOC DEVICE WITH A 2-0 PANACRYL (ETHICON) OR ETHIBOND (ETHICON) SUTURE WITH A SLIP KNOT AND A MORE RAPIDLY ABSORBING PDS TOP HAT DURING CONCURRENT ACL RECONSTRUCTION. THE PDS RAPIDLOC WAS INSERTED BY PIERCING THE INNER PORTION OF THE MENISCUS WITH THE APPLICATION NEEDLE, ADVANCING IT ACROSS, THE TEAR TO THE DEPTH LIMITING SILICONE SLEEVE, AND DEPLOYING THE "BACKSTOP" BY SQUEEZING THE TRIGGER. AFTER THE SUTURE IS PULLED TO VERIFY PROPER DEPLOYMENT OF THE BACKSTOP, THE TOP HAT IS THEN ADVANCED WITH THE PRE-TIED SLIPKNOT USING A KNOT PUSHER UNTIL THE DESIRED TENSION IS CREATED TO ACHIEVE COMPRESSION ACROSS THE REPAIR. REPORTED COMPLICATION INCLUDED FAILED LATERAL MENISCUS REPAIRS (N-2) IN WHICH THE PATIENTS REQUIRED SUBSEQUENT ARTHROSCOPIC MENISCECTOMY, FAILED MEDIAL AND LATERAL MENISCUS TEARS (N-1) IN WHICH THE PATIENT REQUIRED SUBSEQUENT ARTHROSCOPIC MENISCECTOMY, AND RECURRENT EFFUSIONS AND MEDIAL SIDED PAIN WITH ACTIVITY COUPLED WITH MEDIAL JOINT LINE TENDEMESS AND A POSITIVE MCMURRAY TEST (N-1). IN CONCLUSION, THE MORE RAPIDLY ABSORBING POLYDIOXANONE DEVICE IS EFFECTIVE FOR ALL-INSIDE MENISCAL REPAIR DURING CONCURRENT ACL RECONSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1129938 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention