BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFX SPI PDS+ BI VIO 5IN2 USP4-0 D/A PS-4

    MDR report key: 22478855 · Received July 11, 2025

    Report

    Report Number
    2210968-2025-08061
    Event Type
    Malfunction
    Date Received
    July 11, 2025
    Date of Event
    June 13, 2025
    Report Date
    August 29, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031464698
    PMA / PMN Number
    K192144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 JULY 21, 2025. THE COMPONENT WAS IDENTIFIED AS PRODUCT CODE SXPP2B101. IT WAS REQUESTED THAT HSA ASSESS THE FRACTURE MODE OF THE FAILURE. ACCORDING TO THE INFORMATION, IT WAS REPORTED BREAKAGE NEEDLE. THE PRODUCT RECEIVED FOR ANALYSIS WAS SXPP2B101. VISUAL INSPECTION AND METALLURGICAL ANALYSIS WERE PERFORMED ON THE RETURNED PRODUCT. A FRACTURE WAS OBSERVED AT THE SUTURE ATTACHMENT. THE NEEDLE WAS RECEIVED IN ONE PIECE, 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 IN ORDER TO DETERMINE THE FRACTURE MODE. THE EVALUATION OF (B)(4) REVEALED THE FRACTURE WAS COMPOSED OF MICROVOID COALESCENCE, WHICH IS EVIDENCE OF A DUCTILE OVERLOAD FAILURE. 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4) DATE SENT TO THE FDA: 7/11/2025. H6 COMPONENT CODE: G07002 - PENDING EVALUATION OF RETURNED DEVICE. 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: WAS THERE ANY ADDITIONAL TISSUE DAMAGE AS A RESULT OF SEARCHING FOR THE NEEDLE PIECE? UNK WHAT IS THE MOST CURRENT PATIENT STATUS? UNK CAN YOU IDENTIFY LOT NUMBER OF THE PRODUCT INVOLVED? UNK 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) (B)(6). PLEASE PERFORM AND DOCUMENT THE FOLLOW UP ATTEMPT FOR PRODUCT RETURN. PLEASE DOCUMENT THE SHIPMENT TRACKING NUMBER IN NOTES OR RMAO SECTIONS. THE DEVICE HAS BEEN RECEIVED AT SUKAGAWA AND WILL BE SHIPPED. PLEASE CHECK RMAO. A DEVICE HAS BEEN RECEIVED, HOWEVER IT HAS NOT YET BEEN EVALUATED. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, A MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY 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 WAS RETURNED TO ETHICON FOR EVALUATION. ONE DETACHED NEEDLE AND ONE NEEDLE SUTURE PIECE THAT PERTAINS TO PRODUCT CODE SXPP2B101 WERE RECEIVED FOR ANALYSIS. THIS PRODUCT CODE IS DOUBLE ARMED DURING VISUAL INSPECTION OF THE DETACHED NEEDLE, IT WAS OBSERVED THAT THE NEEDLE WAS NOTED TO BE BROKEN AT THE SWAGE AREA. THE OTHER SECTION OF THE NEEDLE WAS NOT RETURNED FOR EVALUATION. THIS SAMPLE WILL BE SHIPPED TO HSA FOR FURTHER ANALYSIS DUE TO THE NEEDLE BREAKAGE. IN ADDITION, THE NEEDLE SUTURE PIECE WAS VISUALLY INSPECTED, AND NO ISSUES RELATED TO BREAKAGE NEEDLE OR ANOMALIES WERE OBSERVED. IN ADDITION, THE END OF THE SUTURE WAS NOTED TO BE CUT PROBABLY BY A SURGICAL INSTRUMENT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. NO CONCLUSION COULD BE REACHED DUE TO THE SAMPLE NEEDS ADDITIONAL EVALUATION BY HSA. AS PART OF THE ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. CORRECTED DATA: D1 PRODUCT CODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HARTMAN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING HARTMAN SURGERY, THE NEEDLE WAS BROKEN DURING USE. THE DOCTOR DID NOT GRASP ESPECIALLY THE WEAK PARTS OF THE NEEDLE. THE BROKEN PIECES OF THE NEEDLE WERE FOUND THERE, AND IT WAS CONFIRMED THAT NO PIECES WERE LEFT INSIDE THE PATIENT. IT WAS NOT A CONTROL RELEASE NEEDLE. THE PRODUCT WAS USED ON THE DERMIS. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872653 SFX SPI PDS+ BI VIO 5IN2 USP4-0 D/A PS-4 SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE NEW ETHICON INC. 10705031464698

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown