BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 8066936 · Received November 13, 2018

    Report

    Report Number
    2210968-2018-77147
    Event Type
    Injury
    Date Received
    November 13, 2018
    Report Date
    October 29, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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: AM J SPORTS MED. 2011; 39: 1081. DOI: 10.1177/0363546510391178 ADVERSE EVENT RELATED TO (B)(6) MALE PATIENT REPORTED IN: 2210968-2018-77145, 2210968-2018-77144, 2210968-2018-77143 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: NON-HARDWARE POSTERIOR CRUCIATE LIGAMENT RECONSTRUCTION USING KNOT/PRESS-FIT TECHNIQUE WITH PERIOSTEUM-ENVELOPED HAMSTRINGS TENDON AUTOGRAFT" AUTHORS: TAI-YUAN CHUANG, MD; WEI-PIN HO, MD; CHIH-HWA CHEN, MD; MING-HSIN SHIEH, MD; JIANN-JONG LIAU, PHD; CHANG-HUNG HUANG, PHD CITATION: AM J SPORTS MED. 2011; 39: 1081. DOI: 10.1177/0363546510391178 THIS STUDY WAS INTENDED TO PRESENT THE CLINICAL RESULTS OF NON-HARDWARE RECONSTRUCTION OF POSTERIOR CRUCIATE LIGAMENT USING A KNOT/PRESS-FIT TECHNIQUE WITH PERIOSTEUM-ENVELOPED AUTOGENOUS HAMSTRING TENDONS. FROM JULY 2003 TO AUGUST 2007, A TOTAL OF 29 ADULT PATIENTS (20 MEN AND 9 WOMEN; AGE RANGE: 18 TO 45 YEARS OLD) WITH ISOLATED PCL RECONSTRUCTION WERE ENROLLED IN THE STUDY. THEY WERE SURGICALLY TREATED WITH NON-HARDWARE PCL RECONSTRUCTION USING FEMORAL PRESS-FIT TECHNIQUE WITH PERIOSTEUM-ENVELOPED HAMSTRINGS TENDON AUTOGRAFT ON THE TIBIAL SIDE. DURING THE GRAFT PREPARATION, THE ENDS OF EACH TENDON WERE TIED TOGETHER IN A SIMPLE KNOT. THESE KNOTS WERE MAXIMALLY TIGHTENED UNDER CYCLIC MANUAL LOADING. THE KNOTS WERE SUTURED WITH 4 TO 5 STITCHES USING ETHIBOND 2-0 SUTURES (ETHICON). TWO 5-MM STRIPS OF MERSILENE TAPE (ETHICON) WERE PASSED AROUND THE KNOTTED AND LOOPED END OF EACH GRAFT. TO DISTINGUISH BETWEEN THE LOOPS, MERSILENE TAPES (ETHICON) FOR THE SEMITENDINOSUS TENDON WERE MARKED, AND THE TAPE FOR THE GRACILIS TENDON REMAINED UNMARKED. THE PREVIOUSLY HARVESTED PERIOSTEUM WAS SECURELY WRAPPED AND SUTURED AROUND THE TENDON WITH VICRYL 3-0 SUTURE (ETHICON) AT THE PLACE IN WHICH THE TENDON GRAFT NEARED THE TIBIAL TUNNEL OPENING. DURING THE GRAFT PASSAGE, THE MERSILENE TAPES (ETHICON) ON THE 2 GRAFTS WERE SECURED TO THE PREPOSITIONED LOOPED STEEL WIRE. DURING THE FIXATION OF THE TIBIAL SIDE, ETHIBOND 2-0 SUTURE (ETHICON) WAS PASSED FROM THE TIBIAL TUNNEL OPENING BY THIS RIGHTANGLE CLAMP. THE MERSILENE TAPES (ETHICON) WERE SEPARATED AND SECURED TO THE ETHIBOND 2-0 SUTURE (ETHICON). THE MERSILENE TAPE STRIPS (ETHICON) WERE PULLED UNDER THE BONE BRIDGE BY THIS ETHIBOND 2-0 SUTURE (ETHICON). MAXIMUM TRACTION WAS EXERTED ON THE MERSILENE TAPES (ETHICON), AND THE SEMITENDINOSUS TAPE ENDS WERE FIRST TIED WITH 4 KNOTS. REPORTED COMPLICATIONS INCLUDED PAIN DURING MODERATE OR STRENUOUS ACTIVITIES (N-2), SWELLING DURING MODERATE OR STRENUOUS ACTIVITIES (N-1), PARTIAL GIVING WAY SYMPTOMS DURING MODERATE OR STRENUOUS ACTIVITIES (N-2), OCCASSIONS OF FULL GIVING WAY DURING MODERATE OR STRENUOUS ACTIVITIES (N-1), PATELLOFEMORAL CREPITUS PAIN (N-2), SUPERFICIAL WOUND INFECTION (N-1) WHICH WAS RESOLVED AFTER ORAL ANTIBIOTIC USE FOR 1 WEEK, NUMBNESS AROUND THE ORIGINAL TIBIAL INCISION (N-1), AND A (B)(6) MALE PATIENT WITH GRAFT RUPTURE. WITHOUT USING HARDWARE, THIS TECHNIQUE WAS APPLIED FOR PCL RECONSTRUCTION AND MIGHT BE A REASONABLE ALTERNATIVE TO OTHER POPULAR TECHNIQUES FOR FIXATION OF THE HAMSTRING TENDONS FOR PCL RECONSTRUCTION. THIS APPROACH NEEDED NO HARDWARE AND MIGHT BE BENEFICIAL IN MRI INTERPRETATION AND REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903348 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention