BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATAFIX SUTURE

    MDR report key: 10276557 · Received July 15, 2020

    Report

    Report Number
    3010692967-2020-00025
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    June 25, 2020
    Report Date
    July 15, 2020
    Manufacturer
    SURGICAL SPECIALTIES
    Product Code
    NEW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A BATCH REVIEW OF THE REPORTED LOT INDICATES THERE WERE NO NON-CONFORMANCES REPORTS ISSUED FOR THE FINISHED GOODS LOT. THE PRODUCT FROM THIS FINISHED GOODS LOT AND ALL OF THE COMPONENTS MET SURGICAL SPECIALTIES REQUIREMENTS THROUGHOUT THE INCOMING, MANUFACTURING AND THE FINAL INSPECTION PROCESSES. THE NEEDLE IS AN ETHICON COMPONENT. NO SAMPLES WERE RETURNED FOR TESTING OR REVIEW. THERE WERE NO RETAINED SAMPLES AVAILABLE FOR TESTING. ETHICON THIRD PARTY SUMMARY HAS NOT BEEN RECEIVED TO DATE. THE BENDING, FRACTURING, BREAKING OF A NEEDLE CAN OCCUR WHEN NEEDLES ARE GRIPPED WITH A NEEDLE HOLDER, FORCEPS, SURGICAL INSTRUMENT ON OR NEAR THE SWAGED AREA OR NEAR THE TIP OF THE DEVICE, WHEN EXCESSIVE FORCE IS APPLIED, WHEN THE DEVICE(S) ARE USED IN APPLICATIONS INVOLVING TORTUOUS TISSUE OR WITH A NEEDLE TIP DESIGN THAT MAY NOT BE APPROPRIATE FOR THE SPECIFIC TISSUE OR PROCEDURE. WITHOUT REVIEWING THE ACTUAL BROKEN NEEDLE, RECEIVING MAGNIFIED PHOTOS OF THE BROKEN DEVICE OR RESULTS FROM THE THIRD PARTY ANALYSIS, TESTING STERILE DEVICES FROM THE SAME FINISHED GOOD LOT OR RECEIVING DETAILS REGARDING THE TOOLS UTILIZED TO GRASP THE NEEDLE COMPONENT, PROCEDURE PERFORMED OR THE SURGEON¿S TECHNIQUE A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    THE HEALTH AUTHORITY CONTACTED OUR DISTRIBUTOR AND REPORTED THE NEEDLE BROKE ON THE SIXTH STITCH IN A LAPAROSCOPIC MYOMECTOMY WHICH ALSO INCLUDED, LAPAROSCOPIC ADENOMYOMECTOMY, LAPAROSCOPIC INTESTINAL ADHESIOLYSIS, LAPAROSCOPIC PELVIC ENDOMETRIOSIS ELECTROCOAGULATION & HYSTEROSCOPIC CURETTAGE . ONE THIRD OF THE NEEDLE WAS ON THE SUTURE AND TWO-THIRDS EMBEDDED IN THE UTERUS. THE DOCTOR IMMEDIATELY SEARCHED THE NEEDLE SITE TO LOCATE THE BROKEN NEEDLE. IT WAS LOCATED WITHIN A HALF AN HOUR. THE ENTIRE NEEDLE WAS FOUND AND PROCEDURE COMPLETED WITHOUT FURTHER INCIDENT. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738969 STRATAFIX SUTURE 2CT-1 #2 PDO 24 X 24 NEW SURGICAL SPECIALTIES SXPD2B402 MDVP460

    Patients

    Seq Age Sex Outcome Treatment
    1 42