BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 14250834 · Received April 29, 2022

    Report

    Report Number
    2210968-2022-03137
    Event Type
    Injury
    Date Received
    April 29, 2022
    Date of Event
    December 19, 2021
    Report Date
    April 29, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS (VICRYL SUTURE, ETHILON SUTURE, PDS II SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS (VICRYL SUTURE, ETHILON SUTURE, PDS II SUTURE) USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA / EVENTS WERE SUBMITTED VIA 2210968-2022-03135 AND 2210968-2022-03136. CITATION: THE ORTHOPAEDIC JOURNAL OF SPORTS MEDICINE, 10(2), 23259671221077679 DOI: 10.1177/23259671221077679.

    Description of Event or Problem · 0

    TITLE: EFFECT OF SURGEON EXPERIENCE ON LONG-TERM PATIENT OUTCOMES IN SURGICAL REPAIR OF ACUTE ACHILLES TENDON RUPTURE. THE AIM OF THIS STUDY WAS TO EXAMINE WHETHER PATIENT-REPORTED AND FUNCTIONAL OUTCOMES AS WELL AS NUMBER OF ADVERSE EVENTS DIFFER BETWEEN PATIENTS WITH ACUTE ACHILLES TENDON RUPTURE OPERATED ON BY ORTHOPAEDIC RESIDENT SURGEONS AND THOSE OPERATED ON BY SPECIALIST SURGEONS. BETWEEN 2011 AND 2014, 295 PATIENTS TREATED WITH SURGICAL ACHILLES TENDON RUPTURE REPAIR WITH STANDARDIZED TECHNIQUES WERE INCLUDED IN THE STUDY. THE SURGICAL ACHILLES TENDON RUPTURE REPAIR WAS PERFORMED BY THE SURGEON SCHEDULED ON THE DAY OF SURGERY. 118 PATIENTS (MEAN AGE 40+/-7.8 YEARS, 102 MALES) WERE OPERATED BY RESIDENT SURGEONS WHILE 177 PATIENTS (MEAN AGE 40+/-8.9 YEARS, 135 MALES) WERE OPERATED BY SPECIALIST SURGEONS. DURING THE PROCEDURE, THE TENDON ENDS WERE THEN SEWN TOGETHER USING A MODIFIED KESSLER SUTURE WITH TWO (2) 1-0 PDS II SUTURES (ETHICON). THE PARATENON AND FASCIA CRURIS WERE CLOSED USING 3-0 VICRYL (ETHICON) AND THE SKIN WAS CLOSED USING 3-0 ETHILON (ETHICON) SINGLE-INTERRUPTED SUTURES. NO ANTIINFLAMMATORY OR THROMBOPROPHYLACTIC DRUGS WERE GIVEN POSTOPERATIVELY. PATIENT-REPORTED OUTCOMES AND FUNCTIONAL OUTCOMES WERE EVALUATED AT 12 MONTHS POSTOPERATIVELY. COMPLICATIONS INCLUDE SURGICAL SITE INFECTIONS (N=10) AND ACHILLES TENDON RERUPTURE (N=3). IN CONCLUSION, RESIDENT SURGEONS ACHIEVED PATIENT-REPORTED AND FUNCTIONAL OUTCOMES AT LEAST AS GOOD AS THOSE OF SPECIALIST SURGEONS IN SURGICAL ACHILLES TENDON RUPTURE REPAIR, WITH A SIMILAR RISK OF ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103859 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention