BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFXSPI MCL+ UNI UD 9IN 3-0 SA SH

    MDR report key: 22578634 · Received July 23, 2025

    Report

    Report Number
    2210968-2025-08522
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Date of Event
    May 1, 2025
    Report Date
    July 23, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031236516
    PMA / PMN Number
    K151200
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4) H3 INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. ONE EMPTY OPEN FOIL, ONE LABELED WINDING FORMER WITH A DETACHED NEEDLE AND ONE ONE SUTURE OUTSIDE THE FOIL PACKET WERE RECEIVED FOR ANALYSIS. PRODUCT CODE SXMP1B427, LOT 1027HH. UPON VISUAL INSPECTION OF THE SAMPLE, IT WAS OBSERVED THE NEEDLE WAS BROKEN AT THE SWAGE AREA AND A PART OF THE NEEDLE WAS NOTED TO BE ATTACHED TO THE SUTURE. THE SAMPLE WILL BE SHIPPED TO HSA FOR FURTHER ANALYSIS DUE TO THE NEEDLE BREAKAGE. ALSO, MARKS THAT APPEAR TO BE BY USE OF THE SURGICAL INSTRUMENT WERE OBSERVED NEAR THE DAMAGE. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS LOT-SERIAL NUMBER WERE REVIEWED, AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS BATCH. 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. H3 NEEDLE INVESTIGATION SUMMARY: THE PRODUCT RECEIVED FOR ANALYSIS WAS IDENTIFIED AS PRODUCT CODE SXMP1B427. 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. THE NEEDLE WAS NOTED WITH MARKS THAT APPEARS TO BE BY SURGICAL INSTRUMENT. 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 THE SAMPLE 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. THE EVIDENCE OF THIS EXAMINATION INDICATES THAT THE BREAKAGE OCCURRED AT THE ATTACHMENT AREA OF THE NEEDLE DURING USE DUE TO TENSILE OVERLOAD. THERE IS NO EVIDENCE OF ANY MATERIAL FLAW OR DEFECT THAT WOULD CAUSE PREMATURE FAILURE. IN ORDER TO AVOID THIS KIND OF DAMAGE GRASP THE NEEDLE IN AN AREA ONE-THIRD (1/3) TO ONE-HALF (1/2) OF THE DISTANCE FROM THE ATTACHMENT END TO THE POINT. THE NEEDLE BREAKAGE WAS CONFIRMED. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED VIA: WHEN DID THE NEEDLE DETACH/PULL OFF FROM THE SUTURE (IN THE PACKAGE, DURING REMOVAL FROM PACKAGE, DURING HANDLING PRIOR TO USE ON PATIENT OR DURING USE ON THE PATIENT)? PLEASE EXPLAIN. DURING REMOVAL FROM PACKAGE

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. 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. THE NEEDLE WAS NOTED WITH MARKS THAT APPEARS TO BE BY SURGICAL INSTRUMENT. 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 THE SAMPLE 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. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1713191 SFXSPI MCL+ UNI UD 9IN 3-0 SA SH SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM ETHICON INC. 1027HH 10705031236516

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown