BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 7346552 · Received March 16, 2018

    Report

    Report Number
    2210968-2018-71506
    Event Type
    Injury
    Date Received
    March 16, 2018
    Report Date
    March 8, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. 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. DOES THE SURGEON BELIEVE THAT MONOCRYL / VICRYL SUTURE CAUSED OR CONTRIBUTED TO THE INFECTION? IF YES, PROVIDE DETAILS OF EVENT AND SPECIFIC SUTURE PRODUCT CODE. CAN SPECIFIC PATIENT DEMOGRAPHICS BE PROVIDED FOR EACH OF THE SUBJECTS OF THIS ARTICLE? IF YES, PLEASE INCLUDE: DATE AND TYPE OF PROCEDURE, WHERE PROCEDURE WAS PERFORMED, SPECIFIC MEDICAL/SURGICAL INTERVENTION PER PATIENT, PRODUCT INVOLVED, PRE-EXISTING CONDITIONS. PRODUCT CODE AND LOT NUMBER OF PRODUCT USED? WERE ANY CULTURES PERFORMED? IF YES WHAT WAS THE RESULT?

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE ENTITLED: A PROSPECTIVE RANDOMIZED COMPARISON OF 2 SKIN CLOSURE TECHNIQUES IN ACETABULAR FRACTURE SURGERY. AUTHORS: CHRISTOPHER D. MUDD, JOHN A. BOUDREAU, BERTON R. MOED. CITATION: J ORTHOPAED TRAUMATOL. 2014; 15:189 194. DOI: 10.1007/S10195-013-0282-7. THE PURPOSE OF THIS PROSPECTIVE CLINICAL STUDY WAS TO ANSWER THE FOLLOWING QUESTIONS: WILL CLOSURE OF A KOCHER-LANGENBECK (K-L) INCISION AFTER ACETABULAR FRACTURE SURGERY WITH A RUNNING SUBCUTICULAR MONOCRYL SUTURE, THEN SEALING THE WOUND WITH DERMABOND, RESULT IN A LOWER INFECTION RATE COMPARED TO METALLIC STAPLE CLOSURE? DO INCISIONS CLOSED WITH SUBCUTICULAR MONOCRYL AND DERMABOND EXHIBIT DECREASED DRAINAGE? AND IS THERE A COST DIFFERENCE BETWEEN THESE TWO METHODS? A TOTAL OF 103 PATIENTS WITH ISOLATED ACETABULAR FRACTURES UNDERWENT ACETABULAR FRACTURE SURGERY. OF WHICH, 51 PATIENTS UNDERWENT SUPERFICIAL CLOSURE OF THE K-L INCISION WITH A RUNNING SUBCUTICULAR MONOCRYL 3-0 SUTURE THEN SEALED WITH DERMABOND SKIN ADHESIVE AND 52 PATIENTS UNDERWENT SKIN CLOSURE WITH METALLIC STAPLES. DURING SURGERY, A STANDARD K-L SURGICAL APPROACH WITHOUT EXTENSION OR TROCHANTERIC OSTEOTOMY WAS USED IN ALL CASES. INTRAOPERATIVELY, ALL PATIENTS RECEIVED IDENTICAL DEEP CLOSURE OF THE FASCIA USING VICRYL 0 INTERRUPTED SUTURES AND MONOCRYL 2-0 INTERRUPTED SUBDERMAL SUTURES. IN THE SKIN CLOSURE WITH METALLIC STAPLES GROUP, REPORTED COMPLICATION INCLUDED A DEEP INFECTION IN A (B)(6) MALE. THE INFECTION DEVELOPED IN THE IMMEDIATE POSTOPERATIVE PERIOD, REQUIRING MULTIPLE IRRIGATIONS AND DEBRIDEMENTS WITH DELAYED CLOSURE OVER ANTIBIOTIC BEADS. THE PATIENT WAS HEALTHY, WITHOUT MEDICAL CO-MORBIDITIES, AND HAD SUSTAINED ISOLATED ACETABULAR FRACTURES (POSTERIOR WALL AND TRANSVERSE PLUS POSTERIOR WALL, RESPECTIVELY) IN A MOTOR VEHICLE ACCIDENT. BMI WAS GREATER THAN 25. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187544 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention