BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE

    MDR report key: 23248233 · Received October 8, 2025

    Report

    Report Number
    2210968-2025-11561
    Event Type
    Malfunction
    Date Received
    October 8, 2025
    Date of Event
    September 7, 2025
    Report Date
    December 11, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    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). H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. 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. ATTEMPTS HAVE BEEN 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED VIA: EVENT DESCRIPTION: DURING CLOSURE OF UTERUS DURING C-SECTION, NEEDLE TIP WAS FOUND TO HAVE BROKEN OFF. SUGGESTED TO CHECK BY X-RAY WHETHER TIP WAS IN OPERATIVE FIELD BUT NURSING STAFF SUGGESTED TIP WOULD BE TOO SMALL TO SEE ON X-RAY. PHYSICIAN WAS SUTURING THE UTERUS CLOSED DURING A C-SECTION. THEY WERE DOING A FIGURE 8 SUTURE AND HAD PROTECTED THE NEEDLE THE TIE THE KNOT. WHEN THEY THEN UNPROTECTED THE NEEDLE AGAIN TO DO THE NEXT PASS, THEY NOTICED THAT THE TIP OF THE NEEDLE WAS NO LONGER SHARP AND HAD BROKEN OFF. SMALL AMOUNT (MAYBE .5 MM). PHYSICIAN TEAM CHECKED SURGICAL FIELD FOR BROKEN PIECE BUT FELT TOO TINY TO BE IDENTIFIED ON XRAY. PROCEDURE WAS COMPLETED AND PATIENT WAS MADE AWARE OF THIS ISSUE AFTER PROCEDURE. IF OTHER, DESCRIBE: C-SECTION. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES. IF YES, NUMBER OF MINUTES: 5. ACTION TAKEN WHEN EVENT OCCURRED? VISUALLY INSPECTED BUT NOT FOUND TIP. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? YES. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? NO. IF NO, EXPLAIN: TIP COULD NOT BE FOUND. PATIENT STATUS/ OUTCOME / CONSEQUENCES: - PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? UNKNOWN. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST: TRUE. ADDITIONAL INFORMATION REQUESTED: WAS THERE ANY CHANGE IN THE PATIENT¿S POST-OPERATIVE CARE DUE TO THE PROLONGED PROCEDURE? NO. WERE THERE PATIENT CONSEQUENCES? IF YES, PLEASE SPECIFY. WAS THERE ANY ADDITIONAL TISSUE DAMAGE AS A RESULT OF SEARCHING FOR THE NEEDLE TIP? NO. ARE THERE ANY PLANS TO CONTINUE SEARCHING FOR THE NEEDLE INSIDE THE PATIENT OR ANY DIFFERENT POST OP TREATMENT? IF YES, PLEASE EXPLAIN. NO. PLEASE PROVIDE LOT NUMBER.109M2X. PLEASE PROVIDE THE STATUS OF THE DEVICE(S) AS IT HAS NOT BEEN RECEIVED FOR ANALYSIS. IF THE DEVICE HAS BEEN SHIPPED, PLEASE PROVIDE THE SHIPMENT TRACKING DETAILS. SUTURE/NEEDLE WAS PROVIDED DIRECTLY TO REP (PLEASE REFER TO THE ATTACHED EMAIL) ON (B)(6) 2205. PROVIDE THE SOURCE OR NAME AND TITLE OF EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (EXTERNAL PERSON SUBMITTING ANSWERS TO SALES REP). ADDITIONAL H11: IF OTHER, DESCRIBE: C-SECTION. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES. IF YES, NUMBER OF MINUTES: 5. ACTION TAKEN WHEN EVENT OCCURRED? VISUALLY INSPECTED BUT NOT FOUND TIP. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? YES. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? NO. IF NO, EXPLAIN: TIP COULD NOT BE FOUND. PATIENT STATUS/ OUTCOME / CONSEQUENCES: - PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? UNKNOWN. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. "D4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THEREFORE, (01) GTIN IS NOT AVAILABLE.

    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. ADDITIONAL INFORMATION: H6, D9, H3. H3 INVESTIGATION SUMMARY: THE PRODUCT RECEIVED FOR ANALYSIS WAS J340 VISUAL INSPECTION AND METALLURGICAL ANALYSIS WERE PERFORMED ON THE RETURNED PRODUCT. A FAILED SUTURE NEEDLE, LABELED AS (B)(4), WAS SUBMITTED TO HERRERA, STAFFORD AND ASSOCIATES, LLC (HSA) FOR FRACTOGRAPHIC EVALUATION ON OCTOBER 27, 2025. THE COMPONENT WAS IDENTIFIED AS PRODUCT CODE J340. IT WAS REQUESTED THAT HSA ASSESS THE FRACTURE MODE OF THE FAILURE. A FRACTURE WAS OBSERVED AT THE TIP OF THE NEEDLE. ONE SIDE OF THE NEEDLE WAS RECEIVED, THE MATING FRACTURE SURFACE WAS NOT PROVIDED FOR THIS EVALUATION. A SCANNING ELECTRON MICROSCOPE (SEM) WAS USED TO EXAMINE THE FRACTURE SURFACES AND SURROUNDING AREA OF THE NEEDLE. THE FRACTURE SURFACES WERE EXAMINED IN MULTIPLE LOCATIONS TO DETERMINE THE FRACTURE MODE. THE EVALUATION OF (B)(4) REVEALED THE FRACTURE WAS COMPOSED OF MICROVOID COALESCENCE, WHICH IS EVIDENCE OF A DUCTILE FRACTURE MODE. MECHANICAL DAMAGE OBSERVED COINCIDENTAL TO THE FRACTURE PROVIDES ADDITIONAL EVIDENCE THAT THE FAILURE WAS INDUCED BY MECHANICAL DEFORMATION LEADING TO DUCTILE OVERLOAD. THIS WAS A DUCTILE FRACTURE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO NON-CONFORMANCE'S WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A OB-GYN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING CLOSURE OF UTERUS DURING C-SECTION, NEEDLE TIP WAS FOUND TO HAVE BROKEN OFF. SUGGESTED TO CHECK BY X-RAY WHETHER TIP WAS IN OPERATIVE FIELD BUT NURSING STAFF SUGGESTED TIP WOULD BE TOO SMALL TO SEE ON X-RAY. PROCEDURE WAS COMPLETED AND PATIENT WAS MADE AWARE OF THIS ISSUE AFTER PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222268 VICRYL POLYGLACTIN 910 SUTURE SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM ETHICON INC. 109M2X

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown