BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHILON BLK 45CM M0.7::USP6/0 SGLE ARMED PS-3 PRIM MP

    MDR report key: 9829491 · Received March 13, 2020

    Report

    Report Number
    2210968-2020-02024
    Event Type
    Malfunction
    Date Received
    March 13, 2020
    Date of Event
    January 1, 2020
    Report Date
    February 19, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 04/09/2020. INVESTIGATION SUMMARY: IT WAS REPORTED BREAKAGE SUTURE. ONE EMPTY LABELED WINDING FORMER AND ONE NEEDLE-SUTURE PIECE IN TWO SECTION OF PRODUCT CODE MPE7662 WERE RECEIVED FOR ANALYSIS. DURING THE VISUAL INSPECTION OF THE OPENED SAMPLE, THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. HOWEVER, MARKS ON THE BODY NEEDLE AND THE END OF THE SUTURE PIECES CUT THAT APPEARS TO BE BY THE USE OF A SURGICAL INSTRUMENT COULD BE OBSERVED. THE OTHER SECTIONS OF THE SUTURE WERE EXAMINED, DAMAGED ON THE SURFACE THAT APPEARS TO BE BY USE OF SURGICAL INSTRUMENT WERE OBSERVED AND THE END OF THE SUTURE WAS CUT AND WAS MATCHED WITH THE EXTREME OF THE NEEDLE/SUTURE PIECE. ADDITIONALLY, THE FUNCTIONAL TEST WAS PERFORMED AND THE TENSILE STRENGTH FORCE WAS ABOVE THE MINIMUM REQUIREMENT. 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. THE MANUFACTURING RECORDS WERE REVIEWED, AND THE MANUFACTURING/PACKAGING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS BATCH. DUE TO CONDITION OF THE OPENED SAMPLE, THE ASSIGNABLE CAUSE OF PERFORMANCE BREAKAGE SUTURE SUGGESTS AN IMPROPER HANDLING.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER PEB903-XAMPE7662, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS THE REPORTED DEVICE ISSUE RELATED TO NEEDLE PULL OFF OR SUTURE BREAKAGE? SUTURE BREAKAGE WHEN DID THE EVENT OCCURRED; DURING DISPENSING OR DURING USE ON PATIENT? DURING THE USE. WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE PROLONGED SURGERY TIME? NO. WAS THE PATIENT TREATMENT ALTERED IN ANYWAY DUE TO THE PROLONGED SURGERY TIME? IF YES, PLEASE EXPLAIN NO. HOW MANY DEVICES WERE INVOLVED IN THIS SINGLE PROCEDURE? 3. PATIENT¿S CURRENT STATUS? DOING WELL. 4 DEVICE RETURNED AND EVENTS REPORTED IN 2210968-2020-02023, 2210968-2020-02025, 2210968-2020-02026.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A DENTAL PROCEDURE IN 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD BROKE AT THE LEAVING OF THE SHUTTLE. THE DEVICE IS TOO FRAGILE. USE OF ANOTHER DEVICE TO COMPLETE THE PROCEDURE WITH 30 MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293151 ETHILON BLK 45CM M0.7::USP6/0 SGLE ARMED PS-3 PRIM MP SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC. PEB903

    Patients

    Seq Age Sex Outcome Treatment
    1