BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 22171416 · Received June 9, 2025

    Report

    Report Number
    2210968-2025-06534
    Event Type
    Injury
    Date Received
    June 9, 2025
    Date of Event
    June 28, 2024
    Report Date
    June 9, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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. CITATION: ANN COLOPROCTOL. 2024 JUN;40(3):217-224. HTTPS://DOI.ORG/10.3393/AC.2022.01144.0163. EPUB 2024 JUN 28. PMID: 38946092; PMCID: PMC11362758.

    Description of Event or Problem · 0

    IMMEDIATE SPHINCTER REPAIR FOLLOWING FISTULOTOMY FOR ANAL FISTULA: DOES IT IMPACT THE HEALING RATE AND SEPTIC COMPLICATIONS? THE AIM OF THIS STUDY IS TO COMPARE THE FISTULA HEALING RATE AND POSTOPERATIVE INFECTIOUS COMPLICATIONS BETWEEN PATIENTS WHO UNDERWENT FIPS AND THOSE WHO UNDERWENT FISTULOTOMY WITHOUT SPHINCTER REPAIR. A RETROSPECTIVE CHART REVIEW WAS CONDUCTED OF ALL CONSECUTIVE PATIENTS WITH ANAL FISTULA OF CRYPTOGLANDULAR ORIGIN WHO UNDERWENT FIPS OR FISTULOTOMY WITHOUT PRIMARY SPHINCTER REPAIR OVER A 10-YEAR PERIOD. ALL OPERATIONS WERE PERFORMED BY A SINGLE COLON AND RECTAL SURGEON (MAA) AT KAISER PERMANENTE (LOS ANGELES, CA, USA). THE CHOICE OF OPERATION AND SELECTIVE ADDITION OF SPHINCTER REPAIR WERE BASED ON THE SURGEON'S JUDGMENT FOR PATIENTS PERCEIVED TO BE AT HIGHER RISK FOR ANAL INCONTINENCE. ADDITIONALLY, FISTULOTOMY WITH SPHINCTER RECONSTRUCTION WAS PERFORMED WHEN OTHER SPHINCTER-PRESERVING TECHNIQUES WERE NOT VIABLE OPTIONS BASED ON INDIVIDUAL CASE ASSESSMENTS. THIS INCLUDED PATIENTS WITH PRIOR FAILED FIBRIN GLUE, PLUG, OR FLAP PROCEDURES; PATIENTS WITH ANAL SCARRING AND SOME DEGREE OF STENOSIS; AND PATIENTS WITH DIFFICULT BODY HABITUS AND A POSTERIOR-BASED FISTULA WHO WERE NOT SUITABLE CANDIDATES FOR A FLAP OPERATION. A TOTAL OF 152 PATIENTS MET THE ELIGIBILITY CRITERIA FOR INCLUSION IN THIS RETROSPECTIVE REVIEW. GROUP A CONSISTED OF 45 PATIENTS WHO UNDERWENT FIPS, WHILE GROUP B COMPRISED 107 PATIENTS WHO UNDERWENT FISTULOTOMY WITHOUT SPHINCTEROPLASTY. THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN GROUPS A AND B IN TERMS OF MEDIAN AGE (46 VS. 45 YEARS, P=0.16) OR MALE SEX (80.0% VS. 88.7%, P=0.20). IN CASES OF FISTULOTOMY WITHOUT SPHINCTER REPAIR IN PATIENTS WITH LONG SUBCUTANEOUS TRACTS, THE EDGES OF THE WOUND WERE MARSUPIALIZED USING 3.0 VICRYL SUTURES IN A RUNNING FASHION. FOR PATIENTS WHO UNDERWENT PRIMARY SPHINCTER REPAIR, THE EXTERNAL SPHINCTER AND, IN SELECT CASES, THE INTERNAL SPHINCTER MUSCLE WAS APPROXIMATED USING 2.0 POLYDIOXANONE (PDS) SUTURES IN A HORIZONTAL MATTRESS FASHION. FINALLY, THE EDGES OF THE WOUND WERE MARSUPIALIZED BY TACKING THE ANODERM TO THE MUSCLE REPAIR USING 3.0 VICRYL SUTURES IN A RUNNING FASHION. REPORTED COMPLICATIONS ARE: 2.0 POLYDIOXANONE (PDS) SUTURES (ETHICON) HEALING RATE OF 93.3% (N=42) IN GROUP A TREATMENT: NOT REPORTED POSTOPERATIVE SEPSIS (N=3) IN GROUP A TREATMENT: NOT REPORTED GAS (NEW POSTOPERATIVE INCONTINENCE) (N=4) IN GROUP A TREATMENT: NOT REPORTED LIQUID AND/OR SOLID STOOL (NEW POSTOPERATIVE INCONTINENCE) (N=4) IN GROUP A TREATMENT: NOT REPORTED 3.0 VICRYL SUTURES (ETHICON) HEALING RATE OF 93.3% (N=42) IN GROUP A TREATMENT: NOT REPORTED HEALING RATE OF 90.6% (N=97) IN GROUP B TREATMENT: NOT REPORTED POSTOPERATIVE SEPSIS (N=3) IN GROUP A TREATMENT: NOT REPORTED POSTOPERATIVE SEPSIS (N=4) IN GROUP B TREATMENT: NOT REPORTED GAS (NEW POSTOPERATIVE INCONTINENCE) (N=4) IN GROUP A TREATMENT: NOT REPORTED GAS (NEW POSTOPERATIVE INCONTINENCE) (N=6) IN GROUP B TREATMENT: NOT REPORTED LIQUID AND/OR SOLID STOOL (NEW POSTOPERATIVE INCONTINENCE) (N=4) IN GROUP A TREATMENT: NOT REPORTED LIQUID AND/OR SOLID STOOL (NEW POSTOPERATIVE INCONTINENCE) (N=9) IN GROUP B TREATMENT: NOT REPORTED IN CONCLUSION, FISTULOTOMY WITH PRIMARY SPHINCTER REPAIR DEMONSTRATED A COMPARABLE HEALING RATE TO FISTULOTOMY ALONE, WITHOUT AN INCREASED RISK OF POSTOPERATIVE SEPTIC COMPLICATIONS. FURTHER PROSPECTIVE RANDOMIZED STUDIES ARE NEEDED TO CONFIRM THESE FINDINGS AND TO EXPLORE THE FUNCTIONAL OUTCOMES OF PATIENTS WHO UNDERGO SPHINCTEROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1334155 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention