BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATAFIX SUTURE

    MDR report key: 10976408 · Received December 9, 2020

    Report

    Report Number
    3010692967-2020-00038
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Date of Event
    November 12, 2020
    Report Date
    December 9, 2020
    Manufacturer
    SURGICAL SPECIALTIES
    Product Code
    GAM
    UDI-DI
    10705031228068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE RECEIVED FOR REVIEW. THERE WERE NO RETAINED SAMPLES AVAILABLE FOR TESTING. THE THIRD PARTY EVALUATION SUMMARY WAS NOT RECEIVED TO DATE. IF SAMPLES OR THE REPORT BECOME AVAILABLE AT A LATER TIME, THEY WILL BE REVIEWED AND THE RESULTS WILL BE INCLUDED IN THE FILE. A BATCH REVIEW OF THE REPORTED LOT CONFIRMED THERE WERE NO NON-CONFORMANCE REPORTS ISSUED FOR THE FINISHED GOODS LOT. THE PRODUCT FROM THIS FINISHED GOODS LOT AND ALL OF THE COMPONENTS MET REQUIREMENTS THROUGHOUT THE INCOMING, MANUFACTURING IN-PROCESS AND THE FINAL INSPECTION PROCESS. THE NEEDLE IS AN ETHICON SUPPLIED COMPONENT. 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, RECEIVING 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

    DURING A LAPAROSCOPIC SURGERY, WHEN THE NEEDLE WAS CLAMPED BY THE NEEDLE HOLDER, IT WAS FOUND THAT THE NEEDLE WAS BROKEN AND THE BROKEN END COULD NOT BE FOUND. PHOTOS WERE TAKEN AND THE BROKEN NEEDLE WAS LOCATED WITHIN THE ABDOMINAL CAVITY; THE NEEDLE PIECE WAS REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1439341 STRATAFIX SUTURE SH 2-0 MONODERM 20CM GAM SURGICAL SPECIALTIES SXMD1B405 AAFT202 10705031228068

    Patients

    Seq Age Sex Outcome Treatment
    1