BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOCRYL SUTURE 27"(70CM) 4-0 VIO

    MDR report key: 8883530 · Received August 12, 2019

    Report

    Report Number
    2210968-2019-85411
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Date of Event
    July 16, 2019
    Report Date
    July 16, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    UDI-DI
    10705031058699
    PMA / PMN Number
    K960653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY IT WAS REPORTED THAT THE DEVICE HAD PERFORMANCE BREAKAGE SUTURE. THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. IT WAS RECEIVED FOR ANALYSIS AN EMPTY LABELED WINDING FORMER,A NEEDLE AND A DISPENSED SUTURE OF PRODUCT CODE Y304, LOT PAK113. DURING THE INSPECTION VISUAL OF THE SAMPLE, THE SUTURE WAS EXAMINED ALONG OF THE STRAND AND NO DEFECTS, OR DAMAGED WERE OBSERVED. A FUNCTIONAL TEST WAS PERFORMED AND THE TENSILE STRENGTH FORCE WAS ABOVE THE MINIMUM REQUIREMENT. IN ADDITION, THE NEEDLE WAS EXAMINED, AND THE SWAGE AND ATTACHMENT AREA WERE NOT AS EXPECTED; SINCE THE NEEDLE WAS SPLIT AND BROKEN ON THE SWAGE. THE MANUFACTURING RECORDS WERE REVIEWED, AND THE MANUFACTURING/ PACKAGING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS BATCH. PER THE CONDITION OF THE SAMPLE, NO PERFORMANCE - BREAKAGE SUTURE WAS FOUND AND THE TESTED SAMPLES MET THE FINISHED GOODS REQUIREMENTS. ADDITIONAL EVALUATION BY NEEDLE BREAKAGE. THE ACTUAL DEVICE NEEDLE COMPONENT WAS IDENTIFIED AS PRODUCT CODE Y304H. A FRACTURE WAS OBSERVED AT THE SUTURE ATTACHMENT OF THE NEEDLE. THE NEEDLE WAS RECEIVED IN TWO PIECES, ONLY ONE OF THE MATING FRACTURE SURFACES WAS EXAMINED FOR THIS EVALUATION. A SCANNING ELECTRON MICROSCOPE (SEM) WAS USED TO EXAMINE THE FRACTURE SURFACES AND SURROUNDING AREA OF THE NEEDLE. THE FRACTURE SURFACES WERE EXAMINED IN MULTIPLE LOCATIONS IN ORDER TO DETERMINE THE FRACTURE MODE. THE EVALUATION OF (B)(4) REVEALED THE FRACTURE WAS COMPOSED OF MICROVOID COALESCENCE, WHICH IS EVIDENCE OF A DUCTILE OVERLOAD FAILURE. MECHANICAL DAMAGE OBSERVED COINCIDENTAL TO THE FRACTURE PROVIDES ADDITIONAL EVIDENCE THAT THE FAILURE WAS INDUCED BY MECHANICAL DEFORMATION LEADING TO DUCTILE OVERLOAD. THIS WAS A DUCTILE FRACTURE. THE EVIDENCE OF THIS EXAMINATION INDICATES THAT THE BREAKAGE OCCURRED AT THE ATTACHMENT AREA OF THE NEEDLE DURING USE DUE TO TENSILE OVERLOAD. THERE IS NO EVIDENCE OF ANY MATERIAL FLAW OR DEFECT THAT WOULD CAUSE PREMATURE FAILURE. IN ORDER TO AVOID THIS KIND OF DAMAGE GRASP THE NEEDLE IN AN AREA ONE-THIRD (1/3) TO ONE-HALF (1/2) OF THE DISTANCE FROM THE ATTACHMENT END TO THE POINT. THE NEEDLE BREAKAGE WAS CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING CONTINUOUS SUTURING THOUGH THE SUTURE WAS NOT HELD WITH FORCEPS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676380 MONOCRYL SUTURE 27"(70CM) 4-0 VIO SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. PAK113 10705031058699

    Patients

    Seq Age Sex Outcome Treatment
    1