BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE

    MDR report key: 20845280 · Received December 4, 2024

    Report

    Report Number
    2210968-2024-12837
    Event Type
    Malfunction
    Date Received
    December 4, 2024
    Date of Event
    November 8, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GDW
    PMA / PMN Number
    K093845
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS PROVIDED: WAS THERE ANY CHANGE IN THE PATIENT¿S POST-OPERATIVE CARE DUE TO THE PROLONGED PROCEDURE? THE OPERATION LASTED 5 TO 10 MINUTES LONGER, WHILE A NEW DEVICE WAS INSERTED. THE PATIENT'S POST-OPERATIVE CARE WAS NOT AFFECTED. ATTEMPTS ARE BEING 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). 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. ADDITIONAL INFORMATION: D9, H3, H6. H3 ANALYSIS SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE STRAP25 DEVICE WAS RETURNED WITH THE CANNULA SHAFT BENT. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, FIRE TESTING WAS NOT CONDUCTED BECAUSE DEVICE FOUND THAT IT WAS RETURNED WITH THE CANNULA SHAFT BENT. THE INSTRUMENT WAS DISASSEMBLED; UPON DISASSEMBLY THIRTEEN (13) STRAPS WERE FOUND INSIDE CANNULA SHAFT. THE EVENT REPORTED WAS CONFIRMED AND IT IS RELATED TO IMPROPER USE OF THE DEVICE. AS PER INSTRUMENT CONDITION, SEEMS THAT THE DEVICE WAS MISHANDLED (APPLICATION OF EXCESSIVE FORCE) AT AN UNKNOWN POINT AND THE CANNULA WAS DAMAGED. AS PART OF ETHICON¿S 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED.

    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. CORRECTED INFORMATION: D4, H4.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE ON (B)(6) 2024 AND ABSORBABLE STRAPS WERE USED. WHEN USED IN THE OPERATING ROOM ON ONE PATIENT, THE STAPLES CAME OUT WITHOUT STAPLING. THE SURGEON THEREFORE OPENED ANOTHER DEVICE TO COMPLETE THE OPERATION. THE OPERATION LASTED 5 TO 10 MINUTES LONGER, WHILE A NEW DEVICE WAS INSERTED. THE PATIENT'S POST-OPERATIVE CARE WAS NOT AFFECTED. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2049601 ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE STAPLE, IMPLANTABLE GDW ETHICON INC. 100L5H

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Male