BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STLESS STEEL UC SIL 30IN 5 S/A TR-55

    MDR report key: 21764165 · Received April 3, 2025

    Report

    Report Number
    2210968-2025-03495
    Event Type
    Injury
    Date Received
    April 3, 2025
    Date of Event
    December 25, 2024
    Report Date
    May 16, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAQ
    UDI-DI
    10705031129931
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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, 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. CORRECTED H6 HEALTH EFFECT - CLINICAL CODE AND IMPACT CODES. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: UPON CONTACT AND VERIFICATION WITH THE HOSPITAL, THE HOSPITAL HAD FEEDBACK THAT THE SUBSEQUENT PATIENT UNDERWENT A SECOND CHEST WALL DEBRIDEMENT SURGERY, AND THE HOSPITAL COULD NOT PROVIDE MORE DETAILED INFORMATION ABOUT THE EVENT. NO SUBSEQUENT ADVERSE EVENTS WERE REPORTED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 4/3/2025. 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, 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WERE THERE PATIENT CONSEQUENCES? IF YES, PLEASE EXPLAIN. WAS\WERE THE NEEDLE PIECE(S) RETRIEVED DURING THE SAME PROCEDURE? WHAT MEASURES WERE TAKEN TO RETRIEVE THE BROKEN PIECE(S)? WAS THERE ANY ADDITIONAL TISSUE DAMAGE AS A RESULT OF SEARCHING FOR THE NEEDLE PIECE(S)? RECEIVED INFORMATION AS FOLLOWING FROM SALES REP VIA PHONE TODAY. PLEASE REFER TO THE EVENT DESCRIPTION, OTHER INFORMATION REQUESTED IS UNKNOWN. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCESS OF CLOSING THE STERNUM, A STERNUM STEEL NEEDLE WAS USED, WHICH WAS INSERTED AND PULLED OUT. HOWEVER, DUE TO THE POOR QUALITY OF THE STEEL NEEDLE, IT BROKE. USE THE C-ARM TO LOCATE AND RETRIEVE THE BROKEN NEEDLE. THERE WERE NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731354 STLESS STEEL UC SIL 30IN 5 S/A TR-55 SUTURE, NONABSORBABLE, STEEL GAQ ETHICON INC. SLBEPL 10705031129931

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female