BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL STAINLESS STEEL SUTURE UNKNOWN PRODUCT

    MDR report key: 7980051 · Received October 18, 2018

    Report

    Report Number
    2210968-2018-76632
    Event Type
    Injury
    Date Received
    October 18, 2018
    Report Date
    October 2, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAQ
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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: WORLD J SURG (2010) 34:1475¿1480, DOI 10.1007/S00268-010-0465-9, PUBLISHED ONLINE: 10 MARCH 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: A MODIFIED NUSS PROCEDURE FOR LATE ADOLESCENT AND ADULT PECTUS EXCAVATUM". AUTHOR: YOO SANG YOON ¿ HONG KWAN KIM ¿ YONG SOO CHOI ¿KWHANMIEN KIM ¿ YOUNG MOG SHIM ¿ JHINGOOK KIM. CITATION: WORLD J SURG (2010) 34:1475¿1480, DOI 10.1007/S00268-010-0465-9, PUBLISHED ONLINE: 10 MARCH 2010. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE THE SAFETY AND EFFICACY OF THE NUSS PROCEDURE IN LATE ADOLESCENTS AND ADULTS WITH PECTUS EXCAVATUM. BETWEEN 2004 AND 2007, A TOTAL OF 44 PATIENTS (MALE: FEMALE = 38:6) WITH A MEDIAN AGE OF 20 UNDERWENT THE NUSS PROCEDURE. DURING THE PROCEDURE, A 30-DEGREE THORACOSCOPE (KARL STORZ, 5-MM WIDE-ANGLE OPTIC THORACOSCOPE) WAS PLACED THROUGH A 5 MM TROCAR INSERTED TWO INTERCOSTAL SPACES BELOW THE LATERAL THORACIC SKIN INCISION. THEN EACH OF THE #5 WIRES (SURGICAL STEEL, ETHICON, 40 MM 1/2C 50 METRIC, TAPECUT) WERE SUTURED THROUGH THE UPPER AND LOWER RIBS NEARLY LATERAL TO THE PUNCTURED INTERCOSTAL SPACE ON BOTH SIDES. AFTER THE #5 WIRE WAS SUTURED ONTO THE STERNUM OF THE ANTERIOR CHEST WALL, WE ELEVATED THE STERNUM BY PULLING THE WIRE UP WITH THE KENT RETRACTOR (JAKASAGO, (B)(4)). THE ROTATED BAR WAS FIXED BY ENCIRCLING AND TWISTING THE WIRES, WHICH WERE PREVIOUSLY TWISTED ONCE, WITH IT. A #5 STEEL WIRE WAS SUTURED WITH EACH OF THE ABOVE OR BELOW RIBS AT THE RIGHT END OR, SOMETIMES, BOTH LATERAL ENDS OF THE BAR. EARLY COMPLICATIONS INCLUDED PNEUMOTHORAX (N=5), PLEURAL EFFUSION (N=1), AND WOUND INFECTION- (N=1) LATE COMPLICATIONS INCLUDED PERICARDITIS AND PERICARDIAL EFFUSION (N=1), SUPERFICIAL SURGICAL SITE INFECTION- (N=2), BAR DISPLACEMENT- (N=2) AND INCOMPLETE CORRECTION- (N=1). FOR EARLY COMPLICATIONS, TUBE THORACOSTOMY IN 2 PATIENTS. FOR LATE COMPLICATIONS, 2 PATIENTS REQUIRED SURGICAL REVISION, 1 PATIENT REQUIRED EARLY BAR REMOVAL. IN CONCLUSION, THE RESULTS OF THIS STUDY SHOW THAT THE NUSS PROCEDURE CAN BE PERFORMED SAFELY AND EFFECTIVELY EVEN IN ADULT PATIENTS, WHEN A COMPOUND BAR TECHNIQUE WITH 3-POINT WIRE FIXATION, THE CRANE TECHNIQUE, AND DOUBLE BAR INSERTION IS EMPLOYED. THE FINDINGS SUGGEST THAT DOUBLE BAR INSERTION MIGHT BE MORE STABLE AND SAFER IN LATE ADOLESCENT AND ADULT PATIENTS WITH A SEVERE PECTUS EXCAVATUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818609 SURGICAL STAINLESS STEEL SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, STEEL GAQ ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention