BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATAFIX

    MDR report key: 17192900 · Received June 23, 2023

    Report

    Report Number
    3010692967-2023-00026
    Event Type
    Malfunction
    Date Received
    June 23, 2023
    Date of Event
    June 9, 2023
    Report Date
    August 15, 2023
    Manufacturer
    SURGICAL SPECIALTIES MEXICO S. DE. R.L. DE C.V.
    Product Code
    NEW
    UDI-DI
    10705031207882
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE NEEDLE COMPONENTS ARE AN ETHICON SUPPLIED COMPONENT. THE TWO FAILED / BROKEN NEEDLES, LABELED AS (B)(4), WERE RECEIVED AT ETHICON¿S THIRD PARTY LABORATORY FOR EVALUATION. THE RESULTS WERE FORWARDED TO SURGICAL SPECIALTIES TO INCLUDE IN THIS REPORT AND AS PART OF THE INVESTIGATION. VISUAL ANALYSIS AND MEASUREMENTS. A FRACTURE WAS OBSERVED IN THE BODY OF SAMPLE A AND SAMPLE B. THE NEEDLES WERE RECEIVED IN TWO PIECES, ONLY ONE OF THE MATING FRACTURE SURFACES WAS EXAMINED FOR THIS EVALUATION. FRACTOGRAPHIC EVALUATION. A SCANNING ELECTRON MICROSCOPE (SEM) WAS USED TO EXAMINE THE FRACTURE SURFACES AND SURROUNDING AREA OF THE NEEDLES. THE SAMPLES WERE 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 CLEANING PROCESS WAS REPEATED TO REMOVE ADHERENT PARTICLES FROM THE FRACTURE SURFACE OF SAMPLE A. SOME DEBRIS REMAINED ON THE SURFACE; HOWEVER ADDITIONAL CLEANING WAS NOT PERFORMED IN ORDER TO PRESERVE THE FINE FRACTOGRAPHIC FEATURES. THE SPECIMENS WERE THEN AIR-DRIED AND STORED UNTIL ANALYSIS. A PROFILE AND TOP VIEW OF THE SAMPLE A, RESPECTIVELY. THE FRACTURE SURFACES WERE EXAMINED IN MULTIPLE LOCATIONS TO DETERMINE THE FRACTURE MODE. THE FRACTURE SURFACE CONTAINED PREDOMINANTLY MICROVOID COALESCENCE (MVC), A FORM OF DUCTILE FAILURE. MECHANICAL DAMAGE IN THE FORM OF INDENTS AND SCRATCHES WERE OBSERVED COINCIDENTAL TO THE FRACTURE. A CUP-AND-CONE SHAPED FRACTURE WAS NOTED. A PROFILE AND TOP VIEW OF THE SAMPLE B FRACTURE, RESPECTIVELY. THE FRACTURE SURFACES WERE EXAMINED IN MULTIPLE LOCATIONS TO DETERMINE THE FRACTURE MODE. THE FRACTURE SURFACE CONTAINED PREDOMINANTLY MICRO VOID COALESCENCE (MVC), A FORM OF DUCTILE FAILURE. MECHANICAL DAMAGE IN THE FORM OF INDENTS AND SCRATCHES WERE OBSERVED COINCIDENTAL TO THE FRACTURE. A CUP-AND-CONE SHAPED FRACTURE AND MACROSCOPIC PLASTIC DEFORMATION WERE NOTED. CONCLUSIONS AND DISCUSSION. THE EVALUATION REVEALED THE FRACTURES WERE COMPOSED OF PREDOMINANTLY MICRO VOID COALESCENCE, WHICH IS EVIDENCE OF A DUCTILE OVERLOAD FAILURE. MECHANICAL DAMAGE, CUP-AND-CONE SHAPED FRACTURES AND MACROSCOPIC PLASTIC DEFORMATION OBSERVED COINCIDENTAL TO THE FRACTURE PROVIDE ADDITIONAL EVIDENCE THAT THE FAILURES WERE INDUCED BY MECHANICAL DEFORMATION LEADING TO DUCTILE OVERLOAD. THESE WERE DUCTILE FRACTURES.

    Additional Manufacturer Narrative · 0

    THERE WAS A POSSIBLE SECOND LOT NUMBER INVOLVED IN THE EVENT. BELOW IS THE UDI INFORMATION. L#: C317TOV. PRODUCT CODE: SXPD2B4021. MANUFACTURE DATE: 03/22/2022. EXPIRATION DATE: 02/28/2027. UDI INFO: (B)(4). A BATCH REVIEW OF THE FINISHED GOOD LOTS AND COMPONENTS CONFIRMED THERE WERE NO QUALITY ISSUES NOTED THROUGHOUT THE INCOMING INSPECTION, MANUFACTURING, STERILIZATION, IN-PROCESS, OR FINAL INSPECTION PROCESS FOR EITHER LOT. NO SAMPLES OR PHOTOGRAPHS OF THE BROKEN DEVICES WERE RETURNED FOR EVALUATION. NO THIRD PARTY EVALUATION REPORT WAS RECEIVED TO DATE. IF SAMPLES, PHOTOS OR THE REPORT BECOMES AVAILABLE AT A LATER TIME, THEY WILL BE REVIEWED, AND THE RESULTS WILL BE INCLUDED IN THE FILE. A FOLLOW-UP REPORT WILL BE SUBMITTED AT THAT TIME. THE BENDING, FRACTURING, BREAKING OF A NEEDLE CAN OCCUR WHEN NEEDLES ARE GRIPPED WITH A NEEDLE HOLDER, FORCEPS OR SOME TYPE OF 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. THE STRESS ON THE ATTACHMENT SECTION IS GREATLY REDUCED WHEN THE NEEDLE IS HELD IN AN AREA ONE-THIRD (1/3) TO ONE-HALF (1/2) OF THE DISTANCE FROM THE SWAGED END TO THE POINT AS INDICATED IN THE IFU FOR THIS PRODUCT. WITHOUT REVIEWING THE ACTUAL BROKEN NEEDLES, REVIEWING STERILE DEVICES FROM THE SAME FINISHED GOOD LOTS, RECEIVING THE RESULTS OF THE THIRD PARTY EVALUATION REPORT FOR THE NEEDLE COMPONENT OR RECEIVING DETAILS REGARDING THE PREOPERATIVE PREPARATION OF THE DEVICE, TOOLS UTILIZED TO GRASP THE NEEDLE COMPONENTS OR UTILIZED IN CONJUNCTION WITH THE MEDICAL DEVICE (ROBOTICS), PROCEDURE PERFORMED OR THE SURGEON¿S TECHNIQUE, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE BROKE WHEN SEWING IN SURGERY. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT''S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE BROKEN NEEDLE WAS RETRIEVED SHORTLY. THE PROCEDURE WAS COMPLETED AND NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1899938 STRATAFIX 2CT-1 #2 PDO 24 X 24 NEW SURGICAL SPECIALTIES MEXICO S. DE. R.L. DE C.V. SXPD2B402 C307RBQ 10705031207882

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O