BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STLESS STEEL SIL 4X18IN 1 S/A V-37

    MDR report key: 21809163 · Received April 9, 2025

    Report

    Report Number
    2210968-2025-03837
    Event Type
    Malfunction
    Date Received
    April 9, 2025
    Date of Event
    February 20, 2025
    Report Date
    April 9, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAQ
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? NO. PATIENT STATUS/OUTCOME/CONSEQUENCES: NO. COULD YOU KINDLY PROVIDE THE LOT NUMBER, PLEASE? I DON'T HAVE THE LOT NUMBER. THE ONLY INFORMATION I HAVE IS ON THE PACKAGING. PLEASE SEE THE PICTURE ATTACHED. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. ONE USED NEEDLE AND ONE SUTURE PIECE OUTSIDE THE FOLDER PACKET WERE RECEIVED FOR ANALYSIS. PRODUCT CODE M660G. DURING THE VISUAL INSPECTION OF THE DETACHED NEEDLE, THE SWAGE AREA AND HOLE WERE NOTED WITH MARKS BY A SURGICAL INSTRUMENT. THE HOLE WAS EXAMINED UNDER MAGNIFICATION AND REMNANT SUTURE INSIDE WAS OBSERVED. IN ADDITION, THE SUTURE WAS INSPECTED, AND THE END WAS NOTED TO BE CUT PROBABLY CAUSED BY A SURGICAL INSTRUMENT. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING CAUTION: TO AVOID THIS KIND OF DAMAGE: GRASP THE NEEDLE IN AN AREA ONE-THIRD (1/3) TO ONE-HALF (1/2) OF THE DISTANCE FROM THE ATTACHMENT END TO THE POINT. AS PART OF THE ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. 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 PEDIATRIC CARDIAC PROCEDURE ON (B)(6) 2025 AND A SUTURE WAS USED. THE SURGEON WAS CLOSING THE STERNUM WITH STAINLESS STEEL WIRES, CALIBER 1. AFTER THE FIRST PASS THROUGH THE BABY'S STERNUM, THE NEEDLE DETACHED FROM THE WIRE, PREVENTING THE SURGEON FROM MAKING THE SECOND PASS TO CLOSE THE THORAX. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1420697 STLESS STEEL SIL 4X18IN 1 S/A V-37 SUTURE, NONABSORBABLE, STEEL GAQ ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown