BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL RAP UND 75CM M3 USP2/0 SGLE ARMED FS-1

    MDR report key: 22700427 · Received August 4, 2025

    Report

    Report Number
    2210968-2025-08984
    Event Type
    Malfunction
    Date Received
    August 4, 2025
    Date of Event
    May 7, 2025
    Report Date
    September 29, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031119956
    PMA / PMN Number
    K033746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. ADDITIONAL INFORMATION: H6, D9, H3. H3 INVESTIGATION SUMMARY: A FAILED SUTURE NEEDLE, LABELED AS (B)(4), WAS SUBMITTED TO HERRERA, STAFFORD AND ASSOCIATES, LLC (HSA) FOR FRACTOGRAPHIC EVALUATION ON AUGUST 13, 2025. THE COMPONENT WAS IDENTIFIED AS PRODUCT CODE VR2253. IT WAS REQUESTED THAT HSA ASSESS THE FRACTURE MODE OF THE FAILURE. ACCORDING TO THE INFORMATION, IT WAS REPORTED PULL OFF - SUTURE NEEDLE THE PRODUCT RECEIVED FOR ANALYSIS WAS VR2253 VISUAL INSPECTION AND METALLURGICAL ANALYSIS WERE PERFORMED ON THE RETURNED PRODUCT. A FRACTURE WAS OBSERVED AT THE SUTURE ATTACHMENT OF THE NEEDLE. THE NEEDLE WAS RECEIVED IN TWO PIECES, ONLY ONE OF THE MATING FRACTURE SURFACES WAS EXAMINED 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. THIS WAS A DUCTILE FRACTURE.

    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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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: WAS\WERE THE NEEDLE PIECE(S) RETRIEVED DURING THE SAME PROCEDURE? WERE X-RAYS TAKEN TO LOCATE THE NEEDLE PIECE(S)? WHAT MEASURES WERE TAKEN TO RETRIEVE THE BROKEN PIECE(S)? WAS THERE ANY ADDITIONAL TISSUE DAMAGE AS A RESULT OF SEARCHING FOR THE NEEDLE PIECE(S)? WERE THERE PATIENT CONSEQUENCES? IF YES, PLEASE SPECIFY IT WAS REPORTED THAT THE EVENT DATE IS MAY 7, 2025, AND THE ALERT DATE IS (B)(6) 2025. COULD YOU PLEASE PROVIDE A JUSTIFICATION FOR THIS VARIANCE IN THE TIMING OF THE REPORT RELATED TO THIS FILE? NOTE A-13444628 REFERENCES "DEVICE 1: VICRYL 2/0" AND "DEVICE 2: VICRYL 3/0." PLEASE CONFIRM IF THESE DEVICES ARE INVOLVED IN THIS COMPLAINT REPORT. IF YES, PLEASE PROVIDE THE PRODUCT CODES AND LOT NUMBERS. PLEASE PERFORM AND DOCUMENT THE FOLLOW UP ATTEMPT FOR PRODUCT RETURN. PLEASE DOCUMENT THE SHIPMENT TRACKING NUMBER IN NOTES OR RMAO SECTIONS. 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). THERE WAS A SLIGHT MISUNDERSTANDING IN THE SPEECH GIVEN BY THE CAREGIVER WHO TOLD US THE FACTS AT THE OUTSET: THE NEEDLE DID NOT BREAK; IT SIMPLY DETACHED FROM THE THREAD. IT REMAINED WELL PLANTED IN THE PATIENT'S SKIN DURING THE PROCEDURE WHEN THE THREAD CAME OFF, BUT IT COULD BE REMOVED IN ONE PIECE AND QUITE EASILY. THE KIT WAS CHANGED AND THERE WERE NO CLINICAL CONSEQUENCES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE IN HALF AND THE HOOKED TIP REMAINED IN THE PATIENT¿S SKIN. THE MIDWIFE WAS ABLE TO REMOVE THE BROKEN NEEDLE. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE NEEDLE DID NOT BREAK, IT SIMPLY DETACHED FROM THE THREAD. IT REMAINED WELL PLANTED IN THE PATIENT'S SKIN DURING THE PROCEDURE WHEN THE THREAD CAME OFF, BUT IT COULD BE REMOVED IN ONE PIECE AND QUITE EASILY. THE KIT WAS CHANGED AND THERE WERE NO CLINICAL CONSEQUENCES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203014 VICRYL RAP UND 75CM M3 USP2/0 SGLE ARMED FS-1 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. AV6313 10705031119956

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown