BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILK BLK 30IN 2-0 S/A FSL

    MDR report key: 14323425 · Received May 7, 2022

    Report

    Report Number
    2210968-2022-03477
    Event Type
    Malfunction
    Date Received
    May 7, 2022
    Date of Event
    April 11, 2022
    Report Date
    June 10, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    UDI-DI
    10705031008076
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # PC- (B)(4). COMPONENT CODE: (B)(4) 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 INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: PLEASE PROVIDE PROCEDURE NAME. THEY WERE USING AS A DRAIN STITCH IN H&N PROCEDURE PLEASE PROVIDE LOT NUMBER. RJBETR 2026-07-31. WAS THERE ANY ADDITIONAL TISSUE DAMAGE AS A RESULT OF SEARCHING FOR THE NEEDLE PIECE? NO. WAS ADDITIONAL DISSECTION REQUIRED IN OTHER ORGANS/TISSUES OTHER THAN THE TARGET TISSUE? NO. WAS THERE ANY CHANGE IN THE PATIENT¿S POST-OPERATIVE CARE DUE TO THE PROLONGED PROCEDURE? NOTHING NOTED. WHAT IS THE MOST CURRENT PATIENT HEALTH STATUS AND CONDITION? NOTHING FURTHER REPORTED ANY PHOTOS AVAILABLE FOR VISUAL ANALYSIS? NO. HOW WAS THE PROCEDURE COMPLETED? REVIEWED AND DECIDED BROKEN PIECE WAS NOT LEFT IN PATIENT. 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 6/10/2022. H6 COMPONENT CODE: G07002 NO DEVICE RETURN. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, 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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE DISTAL 2MM PART OF THE NEEDLE BROKE OFF NEEDLE AND COULD NOT BE RETRIEVED. ALTHOUGH THE FRAGMENT COULDN¿T BE FOUND, THE SURGEON WAS CONFIDENT THAT IT WAS NOT LEFT IN THE PATIENT. THE SURGERY WAS DELAYED FOR AN UNSPECIFIED AMOUNT OF TIME AND WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1233784 SILK BLK 30IN 2-0 S/A FSL SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. 679H RJBETR 10705031008076

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown