BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILK BLK 8X18IN 0 S/A CT-1 CR

    MDR report key: 21918964 · Received April 28, 2025

    Report

    Report Number
    2210968-2025-04566
    Event Type
    Malfunction
    Date Received
    April 28, 2025
    Date of Event
    March 31, 2025
    Report Date
    May 27, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    UDI-DI
    10705031023550
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). CORRECTED INFORMATION: D 9. DEVICE AVAILABLE FOR EVALUATION?, H 3. DEVICE EVALUATED BY MANUFACTURER? ADDITIONAL INFORMATION: D 9. DATE DEVICE RETURNED TO MANUFACTURER, D 9. IS DEVICE RETURNED TO MANUFACTURER?, H 6. COMPONENT CODE, H 6. TYPE OF INVESTIGATION, H 6. INVESTIGATION FINDINGS, H 6. INVESTIGATION CONCLUSIONS H6 COMPONENT CODE: G07002 - NO DEVICE PROBLEM FOUND H3 INVESTIGATION SUMMARY THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. ONE WINDING FORMER WITH A FIVE NEEDLE SUTURE COMBINATION WERE RECEIVED FOR ANALYSIS. THE PRODUCT CODE C021D THAT PERTAIN A CONTROL RELEASE AND REQUIRED EIGHT STRANDS PER PACKET. DURING THE VISUAL INSPECTION OF THE RETURNED SAMPLES, THE NEEDLE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED, NO ANOMALIES OR DEFECTS WERE OBSERVED. IN ADDITION, THE SUTURES WERE MEASURED USING THE TENSIONING BOARD AND FEDERAL GAUGE, AND THE RESULTS MET THE REQUIREMENTS. AS PART OF THE ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS NO ANOMALIES WERE NOTED. ALTHOUGH NO PRODUCT DEFECT WAS IDENTIFIED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE LABORATORY ANALYSIS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A THORACIC DECORTICATION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SCRUB TECH AND THE SURGEON COMMENTED THAT THE SUTURE DID NOT FEEL RIGHT. THEY CLAIMED THE SIZE FELT MORE LIKE A 2.0 SUTURE INSTEAD OF AN 0.0 SUTURE. PROCEDURE WAS COMPLETED WITH THE SAME SUTURE PACK. FOUR SUTURE STRANDS FROM THE SAME PACK ARE AVAILABLE FOR ANALYSIS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1413397 SILK BLK 8X18IN 0 S/A CT-1 CR SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. 103XXH 10705031023550

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown