BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDSII VIO 60IN USP0

    MDR report key: 20463631 · Received October 16, 2024

    Report

    Report Number
    2210968-2024-10792
    Event Type
    Malfunction
    Date Received
    October 16, 2024
    Date of Event
    September 20, 2024
    Report Date
    November 19, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031113459
    PMA / PMN Number
    N18331
    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). DATE SENT TO THE FDA: 11/19/2024. ADDITIONAL INFORMATION: D9, H3, H6. H3 INVESTIGATIONAL SUMMARY: THE PRODUCT RECEIVED FOR ANALYSIS WAS IDENTIFIED AS PRODUCT CODE Z1923E. 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 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. 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). DATE SENT TO THE FDA: 10/16/2024. H6: COMPONENT CODE: G07002 - DEVICE NOT RETURNED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR 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, 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-CONFORMANCE'S WERE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: PLEASE CONFIRM IF THE NEEDLE FELL IN THE PATIENT? NO. IF YES, WAS IT RETRIEVED DURING THE SAME PROCEDURE? WHAT EFFORTS WERE MADE? PLEASE PROVIDE THE SOURCE OR NAME AND TITLE OF THE EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (EXTERNAL PERSON SUBMITTING ANSWERS TO SALES REP) (B)(6). PLEASE PERFORM AND DOCUMENT THE FOLLOW-UP ATTEMPT FOR PRODUCT RETURN. PLEASE DOCUMENT THE SHIPMENT TRACKING NUMBER IN THE NOTES OR RMAO SECTIONS. WE REGULARLY CONTACT WITH SALE REP ABOUT THE DEVICE RETURNING. 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 IN ECM NOTE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE NEEDLE WAS BROKEN. NO, THE PIECE FELL INTO THE PATIENT. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2568286 PDSII VIO 60IN USP0 SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. TDMMPM 10705031113459

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown