BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE

    MDR report key: 17712882 · Received September 8, 2023

    Report

    Report Number
    2210968-2023-06520
    Event Type
    Malfunction
    Date Received
    September 8, 2023
    Date of Event
    January 1, 2023
    Report Date
    December 14, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 12/14/2023. H3 INVESTIGATIONAL SUMMARY: THE PRODUCT RECEIVED FOR ANALYSIS WAS IDENTIFIED AS PRODUCT CODE J340. VISUAL INSPECTION AND METALLURGICAL ANALYSIS WERE PERFORMED ON THE RETURNED PRODUCT. A FRACTURE WAS OBSERVED IN THE BODY OF THE NEEDLE. ONE SIDE OF THE NEEDLE WAS RECEIVED, THE MATING FRACTURE SURFACE WAS NOT PROVIDED FOR THIS EVALUATION. THE NEEDLE WAS NOTED WITH MARKS THAT APPEARS TO BE BY SURGICAL INSTRUMENT. A SCANNING ELECTRON MICROSCOPE WAS USED TO EXAMINE THE FRACTURE SURFACE 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 AND MACROSCOPIC PLASTIC DEFORMATION OBSERVED COINCIDENTAL TO THE FRACTURE PROVIDE 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 FROM MECHANICAL DEFORMATION, INDENTS AND SCRATCHES, DUE TO GRIPPING, BENDING AND OVERSTRESSING OF THE NEEDLE. THERE IS NO EVIDENCE OF ANY MATERIAL FLAW THAT WOULD CAUSE PREMATURE FAILURE. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. 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. PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 12/14/2023. 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 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. . 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: RESPONSE RECEIVED FROM HEALTHCARE PROFESSIONAL ON AUGUST 18, 2023: - DID THE NEEDLE FALL INTO THE PATIENT? YES. IF YES, ¿ WAS THE NEEDLE PIECE(S) RETRIEVED DURING THE SAME PROCEDURE? YES. ¿ WERE X-RAYS TAKEN TO LOCATE THE NEEDLE PIECE(S)? NO. ¿ WHAT MEASURES WERE TAKEN TO RETRIEVE THE BROKEN PIECE? EXTENDED SURGICAL TIME TO RETRIEVE BROKEN NEEDLE. ¿ WAS THERE ANY ADDITIONAL TISSUE DAMAGE AS A RESULT OF SEARCHING FOR THE NEEDLE PIECE? NO. - DOES A PIECE OF THE NEEDLE REMAIN IN THE PATIENT¿S TISSUE? NO. IF YES, ¿ IS THERE ANY PLAN IN PLACE TO REMOVE THE NEEDLE PIECE IN THE FUTURE? ¿ IF YES, PLEASE PROVIDE THE SCHEDULED DATE. ¿ WHAT TISSUE STRUCTURE THE BROKEN NEEDLE WAS LOCATED? ¿ WHAT IS THE SURGEON'S OPINION OF CONSEQUENCES TO THE PATIENT? - DEVICE RETURN STATUS. PLEASE DOCUMENT THE SHIPMENT TRACKING NUMBER: NOT RETURNED. - PLEASE PROVIDE THE SOURCE OR NAME OF PERSON PROVIDING ANSWERS TO FOLLOW-UP QUESTIONS: STEPHANIE INGRAM-COREWELL HEALTH TRENTON FAMILY BIRTHING CENTER, NURSE MANAGER. - WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE PROLONGED SURGERY TIME? NOT AT THIS TIME. - HOW LONG (IN MINUTES) DID THE SURGERY PROLONG? APPROXIMATELY 10-20. - WHAT TISSUE WAS BEING SUTURED WHEN THE EVENT OCCURRED? UTERINE. - WAS ADDITIONAL DISSECTION REQUIRED IN OTHER ORGANS/TISSUES OTHER THAN THE TARGET TISSUE? NO. - WAS THERE ANY CHANGE IN THE PATIENT¿S POST OPERATIVE CARE DUE TO THE PROLONGED PROCEDURE? NOT AT THIS TIME. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE OFF INTO THE PATIENT. THE PIECE WAS LOCATED AND RETRIEVED. THE CASE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. IT IS UNKNOWN IF PIECE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510307 VICRYL POLYGLACTIN 910 SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. RGMJQK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown