BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATAFIX SUTURE

    MDR report key: 10082943 · Received May 22, 2020

    Report

    Report Number
    3010692967-2020-00018
    Event Type
    Malfunction
    Date Received
    May 22, 2020
    Date of Event
    May 13, 2020
    Report Date
    July 13, 2020
    Manufacturer
    SURGICAL SPECIALTIES CORPORATION
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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 SUPPLIED COMPONENT. THE NEEDLE DEVICE WAS RECEIVED BY ETHICON AND FORWARDED TO THEIR THIRD PARTY FOR EVALUATION. A FRACTURE WAS OBSERVED AT THE TIP OF THE NEEDLE. ONE SIDE OF THE NEEDLE WAS RECEIVED, THE MATING FRACTURE SURFACE WAS NOT PROVIDED FOR THIS EVALUATION. SCANNING ELECTRON MICROSCOPE (SEM) WAS USED TO EXAMINE THE FRACTURE SURFACES AND SURROUNDING AREA OF THE NEEDLE. THE SAMPLE WAS ULTRASONICALLY CLEANED WITH A SOLUTION OF TERGAZYME FOR 5-MIN, A HEATED SOLUTION OF ALCONOX FOR 10-MIN, TERGAZYME FOR AN ADDITIONAL 5-MIN, DEIONIZED WATER FOR TWO MINUTES AND ACETONE FOR FIVE MINUTES. THE SPECIMEN WAS THEN AIR-DRIED AND STORED UNTIL ANALYSIS. A PROFILE AND TOP VIEW OF THE NEEDLE FRACTURE WERE EXAMINED IN MULTIPLE LOCATIONS IN ORDER TO DETERMINE THE FRACTURE MODE. THE FRACTURE SURFACE CONTAINED MICROVOID COALESCENCE (MVC), A FORM OF DUCTILE FAILURE. MECHANICAL DAMAGE IN THE FORM OF INDENTS AND SCRATCHES WERE OBSERVED COINCIDENTAL TO THE FRACTURE. THE EVALUATION OF (B)(4) REVEALED THE FRACTURE WAS COMPOSED OF MICROVOID COALESCENCE, WHICH IS EVIDENCE OF A DUCTILE OVERLOAD FAILURE. 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. H3 OTHER TEXT : PLACEHOLDER.

    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

    IT WAS REPORTED BY THE END USER THAT THE NEEDLE WAS FOUND TO BE BROKEN AT THE TIP WHEN CHECKED AFTER LAPAROSCOPIC OVARIECTOMY SURGERY . X-RAYS WERE USED TO SEARCH FOR THE BROKEN TIP BUT IT COULD NOT BE FOUND. IT'S UNKNOWN WHETHER THE BROKEN PIECES WERE LEFT IN PATIENT'S BODY OR NOT. THE PATIENT IS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548085 STRATAFIX SUTURE SH 2-0 MONODERM 20CM SUTURE AND NEEDLE GAM SURGICAL SPECIALTIES CORPORATION SXMD1B405 AAFA200

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R