BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL RAP CT BRD UD 27IN 3-0 S/A FS-1

    MDR report key: 24816982 · Received April 8, 2026

    Report

    Report Number
    2210968-2026-03701
    Event Type
    Malfunction
    Date Received
    April 8, 2026
    Date of Event
    March 16, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 4/8/2026 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: 1.HOW MANY DEVICES DEMONSTRATED THE ALLEGED DEFICIENCY? -ON THE DAY, 7 PCS BREAK FOR 2 PATIENT 2.DID THE EVENT OCCUR DURING ONE OR MULTIPLE PATIENT PROCEDURES? -2 PATIENT 3. WHAT IS THE TOTAL NUMBER OF PROCEDURES? -2 PROCEDURE 4.HAVE ANY OF THESE EVENTS BEEN PREVIOUSLY REPORTED TO ETHICON? IF SO, COULD YOU PLEASE PROVIDE THE CORRESPONDING REFERENCE NUMBER(S)? -NO BECAUSE ONLY HAPPENED AT THE SAME DAY ON 2 PATIENTS. 5. PLEASE PROVIDE THE SOURCE OR NAME AND TITLE OF EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (EXTERNAL PERSON SUBMITTING ANSWERS TO SALES REP OR LOC/BQ, NOT THE PERSON RELAYING/SUBMITTING ANSWERS TO (B)(6) OR (B)(6) . NURSE SURGEON, ETC) (B)(6) (OT INCHARGE) (B)(6) (ORTHO SURGEON) (B)(6) (PHARMASERVE PURCHASER ) (B)(6) ( OT INCHARGE FOR PURCHASING) (B)(6) (PURCHASING IN KPJ PUTERI) 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. D4/G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THEREFORE, (01)GTIN IS NOT AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A ORTHOPAEDIC SURGICAL PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING AN ORTHOPAEDIC SURGICAL PROCEDURE AT KPJ PUTERI SPECIALIST HOSPITAL, THE SURGEON REPORTED THAT THE SUTURE BROKE DURING USE WHILE PERFORMING TISSUE CLOSURE. THE BREAKAGE OCCURRED INTRAOPERATIVELY WHILE THE SURGEON WAS HANDLING THE SUTURE UNDER NORMAL SURGICAL CONDITIONS. DUE TO THE BREAKAGE, THE SURGEON HAD TO REPLACE THE SUTURE WITH ANOTHER ONE IN ORDER TO CONTINUE AND COMPLETE THE PROCEDURE. THE REPEATED BREAKAGE RAISED CONCERNS REGARDING THE PRODUCT PERFORMANCE AND RELIABILITY DURING THE SURGICAL PROCEDURE. NO PATIENT INJURY REPORTED. PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER REPLACING THE SUTURE. THERE WERE NO SURGICAL DELAYS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878730 VCL RAP CT BRD UD 27IN 3-0 S/A FS-1 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. XLBCGMTO

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown