BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 7405042 · Received April 6, 2018

    Report

    Report Number
    2210968-2018-72010
    Event Type
    Injury
    Date Received
    April 6, 2018
    Report Date
    March 20, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. 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? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ANY DEFICIENCY OF THE ETHICON PRODUCT PDS SUTURE CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE? CITATION: ARCH PLAST SURG 2012; 39: 397-403; HTTP://DX.DOI.ORG/10.5999/APS.2012.39.4.397. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN JOURNAL ARTICLE TITLE: FLEXOR TENORRHAPHY USING ABSORBABLE SUTURE MATERIALS AUTHORS: HYUNG JOO KANG, DONG CHUL LEE, JIN SOO KIM, SAE HWI KI, SI YOUNG ROH, AND JAE WON YANG CITATION: ARCH PLAST SURG 2012; 39: 397-403; HTTP://DX.DOI.ORG/10.5999/APS.2012.39.4.397. THE PURPOSE OF THIS COMPARATIVE STUDY WAS TO DETERMINE THE SAFETY AND EFFICACY OF USE OF APPROPRIATE ABSORBABLE CORE SUTURES FOR FINGER FLEXOR TENDON REPAIR IN ZONES 1 TO 5 AS COMPARED WITH THOSE OF THE PUBLISHED ARTCLES ON FLEXOR TENDON REPAIR USING NON-ABSORBABLE SUTURES. THIS STUDY INCLUDES 41 CASES, FROM JUNE 2005 TO DECEMBER 2011, WITH A TOTAL OF 55 FINGERS THAT HAD COMPLETELY RUPTURED FLEXOR TENDONS DUE TO 15 CASES (17 FINGERS) OF CRUSHING INJURY AND 26 CASES (38 FINGERS) OF DEEP LACERATION OF THE HAND. OF THE 41 PATIENTS, THERE WERE 32 MEN AND 9 WOMEN, WITH AN AVERAGE RANGE OF 16 TO 67 YEARS. THE CORE SUTURES USED WERE PDS 4-0 ABSORBABLE SUTURES. THE CIRCUMFERENTIAL REPAIR PROCEDURE WAS A SIMPLE OVER-AND-OVER RUNNING EPITENDINOUS SUTURE TECHNIQUE USING PDS 4-0 SUTURES. AMONG THE 55 INJURED FINGERS OF THE 41 PATIENTS, REPAIR RUPTURE OF THE TENDON WAS SHOWN IN 2 FINGERS OF 2 PATIENTS; SUBSEQUENTLY ONE PATIENT UNDERWENT SECONDARY SURGERY, SPECIFICALLY DELAYED TENORRHAPHY, AND THE OTHER UNDERWENT A PALMARIS LONGUS TENDON GRAFT. IN ONE CASE, REPAIR RUPTURE WAS IDENTIFIED 34 DAYS AFTER THE INITIAL REPAIR AND REQUIRED DELAYED TENORRHAPHY. IN THE OTHER CASE, REPAIR RUPTURE OCCURRED 88 DAYS AFTER THE INITIAL REPAIR, AND REQUIRED A PALMARIS LONGUS (PL) TENDON GRAFT. REPAIR RUPTURE WAS CAUSED BY HYPEREXTENSION AND INFLAMMATION AFTER SURGERY. THE RATE OF COMPLICATIONS SUCH AS REPAIR RUPTURE OR ADHESION WAS SIMILAR FOR PDS AND NON-ABSORBABLE SUTURE MATERIALS. FURTHERMORE, LESS RESTRICTION OF ROM AND SATISFACTORY FUNCTIONAL RECOVERY WERE OBTAINED. THEREFORE, FLEXOR TENDON REPAIR USING ABSORBABLE SUTURE MATERIALS CAN BE USEFUL IN CLINICAL PRACTICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248097 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention