BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFXSPI MCL+ UNI UD 18IN 3-0 SA PS PMP

    MDR report key: 19885395 · Received August 1, 2024

    Report

    Report Number
    2210968-2024-07943
    Event Type
    Malfunction
    Date Received
    August 1, 2024
    Date of Event
    January 1, 2024
    Report Date
    September 3, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031236660
    PMA / PMN Number
    N12159
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 9/3/2024. 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: G07002 PENDING EVALUATION OF RETURNED DEVICE. A DEVICE HAS BEEN RECEIVED, HOWEVER CLARIFICATION IS REQUESTED WHETHER THE PRODUCT BELONGS TO THIS COMPLAINT. THE FOLLOWING INFORMATION WAS REQUESTED: PRODUCT CODE SXMP1B111 LOT TJBEDA. PLEASE CLARIFY IF THE ADDITIONAL DEVICE BELONG TO THIS COMPLAINT? IF YES, DID A DEVICE MALFUNCTION OCCUR DURING THE SAME PROCEDURE? IF NOT, PLEASE CLARIFY IF THE ADDITIONAL RECEIVED PRODUCT BELONGS TO A DIFFERENT COMPLAINT? IF SO, CAN YOU PLEASE PROVIDE THE COMPLAINT NUMBER. IF THE DEVICE WAS NOT REPORTED BEFORE, PLEASE PROVIDE MORE DETAILS OF DEVICE MALFUNCTION. IF THE PRODUCT DOESN¿T BELONG TO ANY COMPLAINT, PLEASE LET US KNOW SO WE CAN DISCARD IT OR ADVISE IF THE PRODUCT IS REQUIRED TO BE RETURNED. IF YOU HAVE THE CORRECT COMPLAINT PRODUCT IN YOUR POSSESSION, PLEASE FORWARD THE PRODUCT TO ETHICON AS SOON AS POSSIBLE. IF YOU HAVE ALREADY SENT THE PRODUCT TO ETHICON, PLEASE REPLY TO [email protected] WITH THE UPS, DHL OR FEDEX TRACKER NUMBER.

    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 WAS REQUESTED AND THE FOLLOWING RESPONSE WAS PROVIDED: WHICH PART OF THE DEVICE BROKE DURING THE PROCEDURE, THE SUTURE OR THE NEEDLE? PLEASE CLARIFY. NEEDLE BROKE FROM SUTURE. WAS THE BROKEN NEEDLE PIECE RETAINED IN PATIENT? IF YES, HOW WAS IT RETRIEVED? NO, IT WAS IN THE SURGEON¿S NEEDLE HOLDER OR TWEEZER. 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE NEEDLE BROKE FROM SUTURE AFTER GOING THROUGH TISSUE. THE SURGEON HAD TO OPEN ANOTHER DEVICE TO FINISH SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2249238 SFXSPI MCL+ UNI UD 18IN 3-0 SA PS PMP SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID GAM ETHICON INC. TKBHZE 10705031236660

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown