BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 20014244 · Received August 21, 2024

    Report

    Report Number
    2210968-2024-08596
    Event Type
    Injury
    Date Received
    August 21, 2024
    Date of Event
    January 1, 2023
    Report Date
    August 16, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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 ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. CITATIONS : THE JOURNAL OF FOOT & ANKLE SURGERY 00.PAGES : 1-5. HTTPS://DOI.ORG/10.1053/J.JFAS.2023.11.014.

    Description of Event or Problem · 0

    TITLE : RADIOLOGICAL ANALYSIS OF THE SYNDESMOSIS CONCEPT IN METATARSUS PRIMUS VARUS AND HALLUX VALGUS DEFORMITIES RECURRENCE PREVENTION THE AIM OF THIS STUDY WAS TO CONDUCT A RADIOLOGICAL MPV STUDY OF EACH FOOT AT SPECIFIC POSTOPERATIVE TIME POINTS, AND OUR SECONDARY AIM WAS TO ASSESS CONCOMITANT HV DEFORMITY CORRECTION WITHOUT FIRST METATARSAL ROTATIONAL CORRECTION (19) OR AKIN OSTEOTOMY. BETWEEN MARCH AND NOVEMBER OF 2009, 55 CONSECUTIVE PATIENTS WERE RECRUITED FROM A SINGLE SURGEON¿S (DYW) PRACTICE TO UNDERGO THE SYNDESMOSIS PROCEDURE ( SP ). TWO DOUBLE-STRAND NO. 2 ABSORBABLE PDS TM (ETHICON, JOHNSON & JOHNSON) AND TWO 2-0 NONABSORBABLE ETHIBOND EXCEL TM (ETHICON, JOHNSON & JOHNSON) SUTURES WERE PASSED THROUGH DRILL HOLES AND AROUND THE SECOND METATARSAL. THE REPORTED COMPLICATIONS INCLUDED SYNOSTOSIS (N=3). IN CONCLUSION, THIS RADIOLOGICAL STUDY OF THE SYNDESMOSIS PROCEDURE FOUND A SIGNIFICANT PATTERN OF A PARTIAL EARLY BUT NOT LATE DEFORMITY RECURRENCE AFTER 6 MONTHS. ITS HIGH RESIDUAL HV DEFORMITY MAY BE REDUCED BY CONSIDERING FUTURE AKIN OSTEOTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2362463 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention