BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATAFIX SUTURE

    MDR report key: 12287675 · Received August 6, 2021

    Report

    Report Number
    3010692967-2021-00028
    Event Type
    Malfunction
    Date Received
    August 6, 2021
    Date of Event
    May 7, 2021
    Report Date
    August 6, 2021
    Manufacturer
    SURGICAL SPECIALTIES
    Product Code
    NEW
    UDI-DI
    10705031227941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BATCH REVIEW OF THE REPORTED LOT INDICATED THERE WERE NO NON-CONFORMANCE REPORTS ISSUED FOR THE FINISHED GOOD LOT. THE PRODUCT FROM THIS FINISHED GOOD 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. NO SAMPLES OR EVALUATION REPORTS WERE RECEIVED TO DATE. THERE WERE NO RETAINED SAMPLES AVAILABLE FOR TESTING. IF SAMPLES OR THE REPORT BECOME AVAILABLE AT A LATER TIME, THEY WILL BE REVIEWED AND THE RESULTS WILL BE INCLUDED IN THE FILE. TO DATE, A THIRD PARTY EVALUATION REPORT HAS NOT BEEN RECEIVED FROM ETHICON. 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. 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.¿ 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

    THE HEALTH AUTHORITY REPORTED TO OUR DISTRIBUTOR THAT ON (B)(6) 2021, DURING A LAPAROSCOPIC HYSTEROMYOMECTOMY WAS PERFORMED, THE PROCESS OF SUTURING THE UTERINE INCISION, THE NEEDLE OF THE ABSORBABLE SURGICAL SUTURE BROKE INTO TWO PARTS. THE BROKEN NEEDLE WAS REMOVED SMOOTHLY AND COMPLETELY DURING THE OPERATION. THE SUTURE WAS REPLACED PROMPTLY TO COMPLETE THE SURGERY. THE OPERATION TIME AND THE OPENING TIME OF THE INCISION WERE PROLONGED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188768 STRATAFIX SUTURE PDO UNI VIO 30CM 0 S/A CT-1 NEW SURGICAL SPECIALTIES SXPD1B401 AAGC918 10705031227941

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other| R