BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOOK NYLON REV CUTTER

    MDR report key: 16527317 · Received March 13, 2023

    Report

    Report Number
    3010692967-2023-00011
    Event Type
    Malfunction
    Date Received
    March 13, 2023
    Date of Event
    March 3, 2023
    Report Date
    March 13, 2023
    Manufacturer
    SURGICAL SPECIALTIES
    Product Code
    GAR
    UDI-DI
    10848782009746
    PMA / PMN Number
    K903029
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. NO ADDITIONAL COMPLAINTS HAVE BEEN REPORTED FOR THIS LOT. NO SAMPLES OR PHOTOGRAPHS OF THE DEFECTIVE DEVICE WERE RETURNED FOR EVALUATION. IF SAMPLES BECOME AVAILABLE AT A LATER TIME, THE DEVICES WILL BE REVIEWED AND TESTED AND THE RESULTS WILL BE INCLUDED IN THE FILE. A FOLLOW-UP REPORT WILL BE SUBMITTED TO YOU AT THAT TIME. THE SUTURE BREAKING FREE FROM THE NEEDLE OR DETACHING FROM THE NEEDLE DURING USE MOST LIKELY RESULTED FROM THE INTERACTION OF SPECIFIC PROCEDURAL RELATED STRESS IN CONTRAST TO THE SUTURE STRENGTH/STRENGTH OF THE ATTACHMENT. IT¿S ALSO POSSIBLE THE DEVICES ARE BEING GRASPED ON OR NEAR THE SWAGED END OF THE NEEDLE, DAMAGING THE SUTURE MATERIAL, ALLOWING THE SUTURE TO BREAK FREE FROM THE NEEDLE DEVICE. 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. THE SURGEON SHOULD AVOID UNNECESSARY TENSION WHEN RUNNING DOWN KNOTS, TO REDUCE THE OCCURRENCE OF SURFACE FRAYING AND WEAKENING OF THE STRAND. 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 FAILED DEVICES, MAGNIFIED PHOTOS OF THE FAILED DEVICES, RECEIVING STERILE SAMPLES FROM THE SAME FINISHED GOOD LOT TO REVIEW/TEST OR RECEIVING DETAILS REGARDING THE METHOD UTILIZED TO REMOVE THE DEVICES FROM THE PACKAGES, PREOPERATIVE PREPARATION OF THE DEVICE(S), TOOLS UTILIZED TO GRASP THE DEVICES, PROCEDURES PERFORMED OR THE SURGEON¿S TECHNIQUE, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 0

    THE SUTURE BROKE AWAY FROM THE THREAD WHILE DR. (B)(6) WAS SUTURING. HE LOST THE SUTURE IN THE PATIENT AND HAD TO GO DIGGING FOR IT. HE GOT IT OUT BUT WANTS TO SWITCH BACK TO THE BRAND HE WAS USING PREVIOUSLY. ALL OF OUR DOCTORS ARE FAIRLY SKILLED SUTURING, DR. (B)(6) IS PROBABLY BY FAR THE MOST EXPERIENCED WITH PROBABLY 30 YEARS OF EXPERIENCE AND THIS WAS NOT USER ERROR. WE UNFORTUNATELY HAVE ALSO HAD ISSUE WITH THE SHARPOINT BRAND. MOSTLY BREAKAGE OF THE THREAD WHEN THEY ARE TYING OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445665 LOOK NYLON REV CUTTER NYLON, 2-0, BLACK, 18" 3/8 CIR RC GAR SURGICAL SPECIALTIES 927B AAFV837 10848782009746

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention