BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 7823887 · Received August 28, 2018

    Report

    Report Number
    2210968-2018-75481
    Event Type
    Injury
    Date Received
    August 28, 2018
    Report Date
    August 10, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT TO THE FDA: 08/28/2018. (B)(4). ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: THE JOURNAL OF FOOT & ANKLE SURGERY. 2014; 53: 350¿352. DOI: HTTP://DX.DOI.ORG/10.1053/J.JFAS.2013.12.025.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: ACHILLES TENDON INFECTION DUE TO MYCOBACTERIUM CHELONAE." AUTHORS: TUN HING LUI, MBBS (HK), FRCS (EDIN), FHKAM, FHKCOS; KWOK BILL CHAN, MBBS (HK), FRCSED (ORTHO), FHKAM, FHKCOS. CITATION: THE JOURNAL OF FOOT & ANKLE SURGERY. 2014; 53: 350¿352. DOI: HTTP://DX.DOI.ORG/10.1053/J.JFAS.2013.12.025. THE AUTHORS REPORTED A CASE MYCOBACTERIUM CHELONAE PARATENDINOUS AND INTRATENDINOUS INFECTION INVOLVING THE ACHILLES TENDON. A (B)(6) YEAR-OLD MALE BARTENDER HAD HIS RIGHT HEEL LACERATED BY BROKEN GLASS IN (B)(6) 2008. EXPLORATION OF THE WOUND WAS PERFORMED ON THE SAME DATE OF INJURY AND REVEALED COMPLETE LACERATION OF THE ACHILLES TENDON WITH MILD WOUND CONTAMINATION AND NO FOREIGN BODY. WOUND DEBRIDEMENT, TENDON REPAIR WITH ETHIBOND 2-0 NON-ABSORBABLE, MULTIFILAMENT, POLYESTER SUTURE (ETHICON) AND WOUND CLOSURE WAS PERFORMED. POST-OPERATIVELY, A SMALL AMOUNT (<1 ML) OF SEROSANGUINOUS DRAINAGE PERSISTED AT THE REPAIR SITE (POST-OPERATIVE PERSISTENT SEROSANGUINOUS DRAINAGE). BY 7 WEEKS POST-OPERATIVELY, AFTER THE ORIGINAL WOUND REPAIR AND CLOSURE, THE RIGHT POSTERIOR ACHILLES WOUND HAD DEHISCED, WITH EXPOSURE OF THE REPAIRED TENDON AND A PORTION OF THE NON-ABSORBABLE SUTURE USED TO RE-APPROXIMATE THE PREVIOUSLY LACERATED TENDON (WOUND SITE DEHISCENCE WITH EXPOSED NON-ABSORBABLE SUTURE). TWO MONTHS AFTER THE ORIGINAL REPAIR, A RETURN VISIT TO THE OPERATING ROOM FOR RE-EXPLORATION OF THE WOUND WAS PERFORMED. INSPECTION OF THE TISSUES AT THE SECOND OPERATION SHOWED SCANT NECROTIC TISSUES AND THE PREVIOUSLY PLACED NON-ABSORBABLE SUTURES HAD LOOSENED THROUGHOUT THE REPAIRED TENDON WHICH REQUIRED WOUND DEBRIDEMENT. SUBSEQUENT MICROBIOLOGIC ASSESSMENTS OF THE SPECIMENS FROM THE DEBRIDED TISSUES AND SUTURES SHOWED BACTERIAL COLONIZATION OF MYCOBACTERIUM CHELONAE WHICH REQUIRED TREATMENT WITH AMIKACIN SULFATE, ORAL CLARITHROMYCIN, AND PARENTERAL IMIPENAM-CILASTATIN. SUBSEQUENT FOLLOW-UP EVALUATIONS UP TO 50 MONTHS AFTER INJURY HAVE SHOWN NO SIGNS OF RECURRENCE OF INFECTION, WITH SATISFACTORY RECOVERY OF THE FUNCTION OF HIS RIGHT ACHILLES TENDON. IT WAS REPORTED THAT THE INFECTION WAS BELIEVED TO HAVE BEEN CAUSED BY DIRECT INOCULATION AT THE ORIGINAL INJURY. IT IS ALSO POSSIBLE THAT THE USE OF A MULTIFILAMENT, NON-ABSORBABLE, BRAIDED SUTURE AT THE ORIGINAL TENDON REPAIR IN A CONTAMINATED WOUND IN THE PATIENT MIGHT HAVE SEQUESTERED MYCOBACTERIA. THIS ¿FOREIGN BODY¿ ACTED TO LOCALLY IMMUNOCOMPROMISE THE WOUND SITE AND MIGHT HAVE MADE THE PATIENT PRONE TO SUBACUTE AND LATE-STAGE INFECTION. THE AUTHORS BELIEVE THAT REPEAT AGGRESSIVE IRRIGATION AND DEBRIDEMENT PROCEDURES COUPLED WITH REMOVAL OF FOREIGN MATERIALS AND THE APPROPRIATE USE OF PROLONGED ANTIBIOTIC THERAPY CAN RESULT IN A SUCCESSFUL LONG-TERM OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663276 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention