BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    STRATAFIX SUTURE

    MDR report key: 11893800 · Received May 27, 2021

    Report

    Report Number
    3010692967-2021-00017
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Date of Event
    May 5, 2021
    Report Date
    August 5, 2021
    Manufacturer
    SURGICAL SPECIALTIES
    Product Code
    GAM
    UDI-DI
    20705031208091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE REPORTED FINISHED GOOD LOT AND RAW MATERIAL COMPONENTS IDENTIFIED NO QUALITY ISSUES DURING THE INCOMING, MANUFACTURING, IN-PROCESS OR FINAL INSPECTION PROCESSES. THE RETAINED SAMPLE FROM THE DEVICE HISTORY RECORD WAS VISUALLY REVIEWED AND FUNCTIONALLY TESTED. NO DEFECTS WERE OBSERVED ON THE NEEDLE/SUTURE. THE SAMPLE MET ALL SPECIFICATIONS INCLUDING THE USP TENSILE TEST/NEEDLE PULL REQUIREMENTS FOR A 2-0 MONODERM¿ DEVICE. TWO (2) SAMPLES WERE RETURNED FOR REVIEW WITH THE WRAPPING CARD AND FOIL PACKAGE LABELED AS LOT NUMBER AAGL025. THE FIRST SUTURE/NEEDLE DEVICE APPEARED USED (TOOL MARKS, ENGAGED BARBS). ONE (1) NEEDLE REMAINED SECURELY ATTACHED TO THE SUTURE WHEN GENTLY TUGGED DURING THE ANALYSIS. NO DAMAGE WAS OBSERVED ON THE NEEDLE OR THE ATTACHMENT. THE BARBS APPEAR ENGAGED; NO UNUSUAL DAMAGE OBSERVED. THERE IS A LOOSE KNOT PRESENT AT THE MIDPOINT ON THE SUTURE. THE END POINT OF FAILURE APPEARS SMOOTH, CUT ON AN ANGLE LIKE WHEN PREPARED FOR THE ATTACHING PROCESS. THERE IS AN INDENTATION MARK NEAR THE END OF THE SUTURE INDICATING THE NEEDLE WAS PREVIOUSLY ATTACHED TO THE SUTURE. THE SECOND NEEDLE WAS NOT RETURNED FOR REVIEW. THE SECOND SUTURE SAMPLE HAD BOTH NEEDLES ATTACHED; NEEDLES WERE SECURELY ATTACHED WHEN GENTLY TUGGED DURING THE ANALYSIS. THE DEVICE APPEARS UNUSED (EX. NO BLOOD, UNENGAGED BARBS). NO DAMAGE WAS OBSERVED ON THE DEVICE. A POSSIBLE ROOT CAUSE FOR THE NEEDLE DETACHING FROM THE SUTURE WHEN REMOVING FROM THE WRAPPING CARD/PACKAGE COULD BE THAT THE SUTURE WAS NOT PLACED DEEP ENOUGH WITHIN THE NEEDLE HOLE DURING THE ATTACHING PROCESS. IT¿S ALSO POSSIBLE THE DEVICES ARE BEING GRASPED ON OR NEAR THE SWAGED END OF THE NEEDLE, DAMAGING THE SUTURE, ALLOWING THE SUTURE TO BREAK FREE FROM THE NEEDLE. THE ¿PRECAUTIONS¿ SECTION IN THE IFU FOR THE DEVICE STATES, ¿CARE SHOULD BE TAKEN TO AVOID DAMAGE WHEN HANDLING. AVOID CRUSHING OR CRIMPING THE SUTURE MATERIAL WITH SURGICAL INSTRUMENTS SUCH AS NEEDLE HOLDERS AND FORCEPS. TO AVOID DAMAGING NEEDLE POINTS AND SWAGE AREAS, GRASP THE NEEDLE IN AN AREA ONE-THIRD (1/3) TO ONE-HALF (1/2) OF THE DISTANCE FROM THE SWAGED END TO THE POINT. THE TYING OF KNOTS ON THE BARBED SECTION OF MATERIAL WILL DAMAGE THE BARBS AND POTENTIALLY REDUCE THEIR EFFECTIVENESS¿. WITHOUT RECEIVING PHOTOS OR THE ACTUAL MISSING NEEDLE 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

    Additional Manufacturer Narrative · 0

    NO SAMPLES WERE RETURNED FOR TESTING OR REVIEW. NO RETAINED SAMPLES ARE AVAILABLE FOR TESTING/REVIEW. IF SAMPLES BECOME AVAILABLE AT A LATER TIME THE DEVICES WILL BE EVALUATED AND THE RESULTS WILL BE INCLUDED IN THE FILE. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE FINISHED GOOD LOT AND THE RAW MATERIAL COMPONENTS IDENTIFIED NO QUALITY ISSUES DURING THE INCOMING, MANUFACTURING, IN-PROCESS OR FINAL INSPECTION PROCESSES. THE NEEDLE COMPONENT IS SUPPLIED BY ETHICON. THE BENDING, FRACTURING, BREAKING OR NEEDLE DETACHING FROM THE SUTURE 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 NEEDLE, RECEIVING MAGNIFIED PHOTOS OF THE DEVICE, 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 · 0

    NEEDLE FELL OFF THE SUTURE WHILE SUTURING THE ANASTOMOSIS AFTER PROSTATECTOMY. THE NEEDLE FELL INTO THE SURGICAL SITE. IT WAS FOUND AFTER 10 MINUTES. NO PATIENT CONSEQUENCES REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795308 STRATAFIX SUTURE 2RB-1 2-0 U MND 16X16 13MM LDR GAM SURGICAL SPECIALTIES SXMD2B402 AAGL025 20705031208091

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R