BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDSII CLR 18IN 4-0 S/A P-3 PRM MP

    MDR report key: 19249767 · Received May 6, 2024

    Report

    Report Number
    2210968-2024-04830
    Event Type
    Malfunction
    Date Received
    May 6, 2024
    Date of Event
    March 14, 2024
    Report Date
    May 29, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031061170
    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

    (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. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: * PLEASE PROVIDE THE LOT NUMBER. > UNK H3 ANALYSIS SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. THE RETURNED SAMPLE DETERMINED THAT IT WAS RECEIVED, ONE DETACHED NEEDLE IN TWO SECTION THAT PERTAIN TO PRODUCT CODE VCP304H. DURING VISUAL INSPECTION OF THE RETURNED SAMPLE, 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. 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. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. THE MANUFACTURING RECORDS COULD NOT BE REVIEWED AS THE BATCH/LOT NUMBER IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). H3 EVALUATION: THE PRODUCT RECEIVED FOR ANALYSIS WAS IDENTIFIED AS PRODUCT CODE . 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 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. 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. THE NEEDLE BREAKAGE WAS OBSERVED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. AFTER OPENING THE PACKAGE, WHEN TRYING TO HOLD THE NEEDLE WITH THE NEEDLE-HOLDER, THE NEEDLE WAS DETACHED FROM THE SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764372 PDSII CLR 18IN 4-0 S/A P-3 PRM MP SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. 10705031061170

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown