BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILK BLK 45CM 6-0 SB-15

    MDR report key: 10580997 · Received September 24, 2020

    Report

    Report Number
    2210968-2020-07271
    Event Type
    Malfunction
    Date Received
    September 24, 2020
    Date of Event
    August 3, 2020
    Report Date
    September 9, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: PLEASE CLARIFY ABOUT "THE SUTURES WERE FRAGILE DURING USE." DID THE SUTURE BREAK? YES THE SUTURE BROKE DURING USE. ANY PATIENT CONSEQUENCES? NO. WHEN DID EVENT OCCUR PRE-OP (BEFORE USE ON PATIENT)? OR INTRA-OP (DURING USE ON PATIENT WHILE SUTURING)? INTRA OP FOR EYE SURGERY. WAS PROCEDURE COMPLETED SUCCESSFULLY? YES, CUSTOMER CHANGE TO NEW DEVICE. INVESTIGATION SUMMARY: SEVEN UNOPENED SAMPLES OF PRODUCT CODE W529H, LOT # MCM976 WERE RETURNED FOR ANALYSIS. DURING THE VISUAL INSPECTION OF THE SEVEN SAMPLES, NO DEFECTS WERE FOUND ON THE PACKAGES. THE SAMPLES WERE OPENED, AND THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED AND NO NEEDLE BREAKAGE WERE NOTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG OF THE STRANDS AND NO DEFECTS, OR DAMAGED WERE OBSERVED. A FUNCTIONAL TEST WAS PERFORMED AND THE PULL FORCE AND TENSILE STRENGTH WERE ABOVE THE MINIMUM REQUIREMENTS. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS LOT-SERIAL NUMBER WERE REVIEWED, AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS BATCH. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. A PAPER LID, AN EMPTY WINDING FORMER, TWO SUTURES PIECES AND A NEEDLE/SUTURE PIECE OF PRODUCT CODE W529H, LOT # MCM976 WERE RETURNED FOR ANALYSIS DURING THE VISUAL INSPECTION OF THE NEEDLE/SUTURE PIECE, THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED AND THE SUTURE END WAS OBSERVED BROKEN. TWO SUTURES PIECE WERE EXAMINED, AND THE ENDS WERE BROKEN AND DAMAGED ON THE SURFACE. DUE TO CONDITION OF THE SAMPLE RECEIVED NO FUNCTIONAL TEST COULD BE PERFORMED. AS WITH ANY DEVICE, CARE SHOULD BE TAKEN TO AVOID DAMAGE TO THE STRAND WHEN HANDLING. AVOID THE CRUSHING OR CRIMPING ACTION OF THE SURGICAL INSTRUMENTS, SUCH AS NEEDLE HOLDERS AND FORCEPS. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS LOT-SERIAL NUMBER WERE REVIEWED, AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS BATCH. NO CONCLUSION COULD BE REACHED AS THE SUTURES WERE FRAGILE DURING USE. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. COMPLAINT INFORMATION WILL BE INCLUDED IN COMPLAINT TRENDING THAT IS REVIEWED ON A REGULAR BASIS TO DETERMINE IF FURTHER ACTION IS NECESSARY. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER MCM976, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE SURGERY ON (B)(6) 2020 AND SUTURE WAS USED. THE SUTURES WERE FRAGILE DURING USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046358 SILK BLK 45CM 6-0 SB-15 SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. MCM976

    Patients

    Seq Age Sex Outcome Treatment
    1