BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE

    MDR report key: 24986379 · Received April 24, 2026

    Report

    Report Number
    2210968-2026-04482
    Event Type
    Injury
    Date Received
    April 24, 2026
    Date of Event
    April 2, 2026
    Report Date
    May 26, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031042582
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, 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. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT: PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? WERE ANY CONCOMITANT PROCEDURES PERFORMED? WHAT WAS THE INITIAL APPROACH FOR THE INDEX SURGICAL PROCEDURE? (OPEN OR MINIMALLY INVASIVE)? ON WHAT TISSUE WAS THE SUTURE USED? WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? WHAT INSTRUMENTS WERE USED TO GRASP THE NEEDLE? WHERE WAS THE NEEDLE GRASPED DURING USE? DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE OR DURING USE? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT'S CURRENT STATUS? LOT NUMBER?

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR CERVICAL SPINE PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED IN CLOSURE. THE USER NOTICED THAT IT FELT LIKE IT WAS MORE DIFFICULT THAN USUAL TO PENETRATE THE TISSUE, AND HANDED IT BACK TO THE SCRUB TECH REQUESTING ANOTHER SUTURE. THE 2ND AND FUTURE SUTURES WORKED AS EXPECTED AND THE CASE WAS CLOSED WITH NO DELAY. AFTER THE CASE, THE SCRUB TECH NOTICED THAT THE PARTICULAR SUTURE WHICH SEEMED DIFFICULT TO PASS WAS MISSING THE TIP OF IT. CONCERNED THAT THE FRAGMENT COULD BE IN THE PATIENT, AN X-RAY WAS TAKEN AND SOMETHING DID APPEAR IN THE PATIENT. SINCE THE PATIENT WAS ALREADY COMPLETELY CLOSED BY THIS TIME, THE SURGEON DECIDED TO WATCH THE PATIENT FOR ANY ILL EFFECTS. THE NEXT DAY THE SURGEON DECIDED TO RE-OPERATE TO RETRIEVE THE FRAGMENT. THE PATIENT WAS BROUGHT BACK TO THE OR ON (B)(6) 2026, AND THE FRAGMENT WAS RETRIEVED VERY QUICKLY. THE PATIENT RECOVERED AND IS DOING AS EXPECTED. IT IS UNKNOWN WHAT COULD HAVE CAUSED THE TIP OF THE NEEDLE TO BREAK OFF. NEITHER THE NEEDLE, NOR THE FRAGMENT WERE SAVED BY OR STAFF TO BE ABLE TO SEND IN FOR INVESTIGATION. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586038 VICRYL POLYGLACTIN 910 SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. 10705031042582

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention