BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDSII UD 27IN 2-0 S/A CT-1

    MDR report key: 24004388 · Received January 8, 2026

    Report

    Report Number
    2210968-2026-00172
    Event Type
    Malfunction
    Date Received
    January 8, 2026
    Date of Event
    December 4, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031060340
    PMA / PMN Number
    N18331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 2/4/2026. 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 INFORMATION: H6. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 1/8/2026. 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 INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: - THE PRODUCTS REFERENCED IN THIS EVENT ARE J&J. HOWEVER, A COMPLAINT WAS FILED WITH MCKESSON MEDICAL-SURGICAL UNDER INTERNAL COMPLAINT NUMBER (B)(4). COULD YOU PLEASE CLARIFY THE DETAILS OF THAT COMPLAINT? - MK (PLEASE REFER TO THE ATTACHED EMAIL) MEDICAL-SURGICAL HAS OPENED THEIR OWN SEPARATE COMPLAINT REGARDING THIS SAME INSTANCE. OUR (MK) (PLEASE REFER TO THE ATTACHED EMAIL) PRODUCT COMPLAINT TEAM HAS SENT THIS OVER TO J&J FOR REVIEW. - PLEASE CONFIRM WHETHER THE SEVEN PRODUCTS LISTED IN THIS COMPLAINT ARE ALL MANUFACTURED BY J&J. - ALL SEVEN PRODUCTS ARE MANUFACTURED BY J&J AND WERE SOLD/SHIPPED BY MK(PLEASE REFER TO THE ATTACHED EMAIL). - PLEASE CONFIRM WHETHER THE PRODUCTS WILL BE SENT TO J&J. - THE PRODUCT WILL NOT BE SENT BACK TO J&J AS J S P (PLEASE REFER TO THE ATTACHED EMAIL) SURGERY DID NOT KEEP THE FAULTY PRODUCT. -HOW MANY DEVICES DEMONSTRATED THE ALLEGED DEFICIENCY IN EACH CASE (B)(6) 2025 AND (B)(6) 2025? -DO YOU HAVE ANY PHOTOS AVAILABLE FOR VISUAL ANALYSIS? THE LAST 10 SUTURES IN THE PACK WERE VERY WEAK AND KEPT BREAKING. THIS HAPPENED WHILE DR. (PLEASE REFER TO THE ATTACHED MAIL) WAS SUTURING A PATIENT ON THURSDAY (B)(6) 2025 AND AGAIN TODAY (B)(6) 2025. I DON'T HAVE PHOTOS. 3 SUTURES BROKE DURING CLOSURE ON (B)(6) 2025 AND 3 OR 4 ON (B)(6) 2025. 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THEY HAVE HAD 2 INSTANCES WHERE THESE SUTURES HAVE BEEN BREAKING OFF DURING SURGERY. IT SEEMS THAT APPROXIMATELY THE LAST 10 SUTURES IN THE PACK WERE VERY WEAK AND KEPT BREAKING. THIS HAPPENED WHILE DR. WAS SUTURING A PATIENT ON (B)(6) 2025 AND AGAIN ON (B)(6) 2025. THEY SAID THAT THERE WERE PROBABLY 7 TOTAL SUTURES OUT OF THAT BOX THAT BROKE WITH VERY LITTLE TENSION AND THEY COULD NOT BE USED. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. DEVICE AVAILABILITY WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532473 PDSII UD 27IN 2-0 S/A CT-1 SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. 10ADK1 10705031060340

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown