BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATAFIX SYMMETRIC PDS UNKNOWN PRODUCT

    MDR report key: 21516485 · Received March 4, 2025

    Report

    Report Number
    2210968-2025-02321
    Event Type
    Injury
    Date Received
    March 4, 2025
    Date of Event
    February 1, 2025
    Report Date
    April 11, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    K182873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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. NO CONTACT INFORMATION WAS PROVIDED; THEREFORE, NO ADDITIONAL INFORMATION HAS BEEN REQUESTED AT THIS TIME. 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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: JOURNAL OF CLINICAL NEUROSCIENCE. VOLUME 134, APRIL 2025.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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. CORRECTED B5 NARRATIVE: TITLE: EXPANDED APPLICATIONS OF KNOTLESS TISSUE CONTROL DEVICES IN NEUROSURGICAL CRANIAL AND SPINAL APPLICATIONS. THIS STUDY AIMED TO EVALUATE THE APPLICATION OF KNOTLESS TISSUE CONTROL DEVICES IN VARIOUS CRANIAL AND SPINAL NEUROSURGICAL APPLICATIONS AS PART OF A QUALITY IMPROVEMENT INITIATIVE. A TOTAL OF 195 PATIENTS WHO UNDERWENT CRANIAL, SPINAL, AND PERIPHERAL NERVE NEUROSURGICAL PROCEDURES FROM (B)(6) 2022 UNTIL (B)(6) 2024 WERE INCLUDED IN THE STUDY. AMONG THESE, 53 (27.2 %) UNDERWENT CRANIAL, 140 (71.8 %) SPINE, AND 3 (1.0 %) PERIPHERAL NERVE PROCEDURES. A SWITCH IN SURGICAL REPAIR STRATEGY FROM CONVENTIONAL SUTURE TECHNIQUES TO STRATAFIX (ETHICON/J&J, RARITAN, NJ), KNOTLESS TISSUE CONTROL WAS PERFORMED IN (B)(6) 2023. A) CRANIAL APPLICATIONS FOR KNOTLESS SUTURE INCLUDE USE OF A 2¿0 PDS SPIRAL KNOTLESS FOR TEMPORALIS MUSCLE AND GALEAL CLOSURE FOLLOWED BY A 3¿0 MONOCRYL SPIRAL KNOTLESS FOR SUBCUTICULAR CLOSURE. B) SPINE TREATMENT INVOLVES CLOSURE OF MUSCULAR DEADSPACE WITH INTERRUPTED SUTURE FOLLOWED BY CLOSURE OF FASCIA WITH 0 PDS SYMMETRIC/BARBED KNOTLESS, DEEP AND SUBDERMAL TISSUE WITH 2¿0 PDS SPIRAL KNOTLESS, AND SUBCUTICULAR WITH 2¿0 MONOCRYL SPIRAL KNOTLESS. REPORTED COMPLICATIONS INCLUDE: 0 PDS SYMMETRIC STRATAFIX (ETHICON) 2¿0 PDS SPIRAL STRATAFIX (ETHICON) MONOCRYL SPIRAL STRATAFIX (2¿0 OR 3¿0; ETHICON) 27-YEAR-OLD FEMALE (N=1) - PSEUDOMENINGOCELE AFTER LUMBAR LAMINECTOMY WITH CEREBROSPINAL FLUID LEAK TREATMENT: NOT REPORTED IN CONCLUSION, KNOTLESS SUTURE TECHNIQUES CAN BE AN EFFECTIVE CLOSURE METHOD FOR A VARIETY OF NEUROSURGICAL TECHNIQUES COMPARABLE TO EXPECTED WOUND COMPLICATION RATES. WE EXPAND ON THE POTENTIAL APPLICATIONS OF THIS TECHNOLOGY COMPARED WITH PRIOR STUDIES. FURTHER STUDIES WILL BE NECESSARY TO CONFIRM THESE FINDINGS. CITATION: J CLIN NEUROSCI. 2025 APR; 134:111108. EPUB 2025 FEB 8. PMID: 39923434. HTTPS://DOI.ORG/10.1016/J.JOCN.2025.111108.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). CORRECTED INFORMATION: B1, B2, H1 - ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE EVENT IS NOT RELATED TO THE DEVICE. THEREFORE, THIS MEDWATCH REPORT IS BEING VOIDED.

    Description of Event or Problem · 0

    TITLE: EXPANDED APPLICATIONS OF KNOTLESS TISSUE CONTROL DEVICES IN NEUROSURGICAL CRANIAL AND SPINAL APPLICATIONS EFFECTIVE WOUND CLOSURE IS ESSENTIAL TO NEUROSURGICAL PROCEDURES. HISTORICAL RATES OF NEUROSURGICAL WOUND COMPLICATIONS RANGE FROM 7 TO 14 %. KNOTLESS SUTURING WITH BARBED SUTURES MAY OFFER EFFECTIVE CLOSURE RATES BUT HAS HAD LIMITED EVALUATION OF SAFETY IN NEUROSURGICAL APPLICATIONS. A TOTAL OF 195 PATIENTS WHO UNDERWENT CRANIAL, SPINAL, AND PERIPHERAL NERVE NEUROSURGICAL PROCEDURES FROM 12/2022 UNTIL 7/2024 WERE INCLUDED IN THE STUDY. AMONG THESE, 53 (27.2 %) UNDERWENT CRANIAL, 140 (71.8 %) SPINE, AND 3 (1.0 %) PERIPHERAL NERVE PROCEDURES. A SWITCH IN SURGICAL REPAIR STRATEGY FROM CONVENTIONAL SUTURE TECHNIQUES TO STRATAFIX (ETHICON/J&J, RARITAN, NJ), KNOTLESS TISSUE CONTROL WAS PERFORMED IN 6/2023. REPORTED COMPLICATIONS INCLUDE SUPERFICIAL DEHISCENCE TREATED WITH WASHOUT (N=3), PSEUDOMENINGOCELES (N=2), CEREBROSPINAL FLUID LEAKS WITH MENINGITIS (N=2), DEEP DEHISCENCE WITH WASHOUT (N=1), SUPERFICIAL DEHISCENCE WITH ANTIBIOTICS (N=1), AND EPIDURAL HEMATOMA (N=1). IN CONCLUSION, KNOTLESS SUTURE TECHNIQUES CAN BE AN EFFECTIVE CLOSURE METHOD FOR A VARIETY OF NEUROSURGICAL TECHNIQUES COMPARABLE TO EXPECTED WOUND COMPLICATION RATES. WE EXPAND ON THE POTENTIAL APPLICATIONS OF THIS TECHNOLOGY COMPARED WITH PRIOR STUDIES. FURTHER STUDIES WILL BE NECESSARY TO CONFIRM THESE FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473716 STRATAFIX SYMMETRIC PDS UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE, (POLIGLECAPRONE 25) NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female Required Intervention