BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFXSPI PDS+ UNI VIO 6IN 3-0 SA SH

    MDR report key: 20524990 · Received October 24, 2024

    Report

    Report Number
    2210968-2024-11072
    Event Type
    Malfunction
    Date Received
    October 24, 2024
    Date of Event
    May 29, 2024
    Report Date
    October 24, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031235809
    PMA / PMN Number
    K182873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, PART 4 SUBPART B. 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 INFORMATION: . PMA / 510(K) K182873.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, PART 4 SUBPART B. 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. H6 COMPONENT CODE: C22 - PHOTO ANALYSIS. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED LATER A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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 SPECIFY. DID ANY NEEDLE PIECE(S) FALL INTO THE PATIENT? IF YES, WAS THE NEEDLE PIECE(S) RETRIEVED DURING THE SAME PROCEDURE? WERE X-RAYS TAKEN TO LOCATE THE NEEDLE PIECE(S)? 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)? IF NOT RETRIEVED, IN WHAT TISSUE STRUCTURE THE NEEDLE PIECE(S) WERE RETAINED? IS THERE ANY PLAN IN PLACE TO REMOVE THE NEEDLE PIECE(S) IN THE FUTURE? PLEASE PROVIDE DETAILS. CONTACTED WITH THE SALES REP TODAY VIA PHONE, PLEASE REFER TO EVENT DESCRIPTION AND OTHER INFORMATION REQUESTED IS UNKNOWN. INVESTIGATION SUMMARY: THIS IS AN ANALYSIS FOR A PHOTO SUBMITTED TO ETHICON FOR EVALUATION. DURING THE VISUAL ANALYSIS, THE FOLLOWING WAS OBSERVED: THE PHOTOS SHOW A CLOSED FOIL LABELED AS SXPP1B420 AND A SECOND IMAGE SHOWS A NEEDLE BROKEN INTO TWO SECTIONS. NO CLEAR ANALYSIS COULD BE PERFORMED DUE TO THE POSITION OF THE NEEDLE. BASED ON THE PHOTO REVIEW, THE EVENT DESCRIBE IS CONFIRMED, HOWEVER NO CONCLUSION OR ROOT CAUSE COULD BE DETERMINED. HANDS ON DEVICE ANALYSIS MAY PROVIDE THE ADDITIONAL EVIDENCE NECESSARY TO CONFIRM THE ROOT CAUSE OF THE REPORTED EVENT. BECAUSE THE DEVICE WAS NOT RETURNED OUR EVALUATION IS LIMITED. AS PART OF ETHICON QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHILE PREPARING TO SUTURE AFTER CLAMPING, THE NEEDLE BROKE AND SEPARATED, MAKING IT UNABLE TO BE USED NORMALLY. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1771903 SFXSPI PDS+ UNI VIO 6IN 3-0 SA SH SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE NEW ETHICON INC. TEBAMM 10705031235809

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male