BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL PLUS VIO 8X45CM M1.5 USP4/0 SGLE ARMED SH C/R

    MDR report key: 25057006 · Received May 1, 2026

    Report

    Report Number
    2210968-2026-04762
    Event Type
    Malfunction
    Date Received
    May 1, 2026
    Date of Event
    April 16, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K181652
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4) DATE SENT TO THE FDA: 5/1/2026. 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, THE FOLLOWING WAS OBTAINED: DID THE REPORTED ISSUE CONTRIBUTE TO ANY PATIENT ADVERSE CONSEQUENCES? WERE X-RAYS TAKEN TO LOCATE THE NEEDLE PIECE(S)? WHAT MEASURES WERE IMPLEMENTED TO RETRIEVE THE BROKEN PIECE? WAS THERE ANY ADDITIONAL TISSUE DAMAGE RESULTING FROM THE SEARCH FOR THE NEEDLE PIECE? - DOES A FRAGMENT OF THE NEEDLE REMAIN IN THE PATIENT¿S TISSUE? IF SO, IS THERE ANY PLAN IN PLACE TO REMOVE THE NEEDLE PIECE IN THE FUTURE? IF SO, COULD YOU PLEASE PROVIDE THE SCHEDULED DATE FOR THE REMOVAL? WHAT IS THE SURGEON¿S OPINION OF THE POTENTIAL CONSEQUENCES FOR THE PATIENT? PLEASE PROVIDE THE SOURCE OR NAME OF PERSON PROVIDING ANSWERS TO FOLLOW-UP QUESTIONS: 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. 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 SCALP CONTUSION WITH INFECTION EXPANSION SURGERY+SCALP SUTURING SURGERY ON (B)(6) 2026 AND SUTURE WAS USED. THE PATIENT UNDERWENT SURGERY DUE TO INTRACRANIAL INJURY. WHEN SUTURING SUBCUTANEOUS ADIPOSE TISSUE WITH SUTURE DURING SURGERY, THE NEEDLE TAIL BROKE. THE HAND WASHING NURSE IMMEDIATELY RETRIEVED THE BROKEN NEEDLE AND COMPARED IT WITH THE END OF THE SUTURE TO CONFIRM THAT THE BROKEN NEEDLE HAD BEEN FULLY RETRIEVED. IMMEDIATELY STOPPED USING THE SUTURE AND REPLACED IT WITH A NEW ONE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58601 VICRYL PLUS VIO 8X45CM M1.5 USP4/0 SGLE ARMED SH C/R SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM ETHICON INC. S23120010

    Patients

    Seq Age Sex Outcome Treatment
    1