BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 90CM VICRYL VIOLET SUTURE SINGLE ARMED CTX M4

    MDR report key: 8623840 · Received May 20, 2019

    Report

    Report Number
    2210968-2019-81513
    Event Type
    Malfunction
    Date Received
    May 20, 2019
    Report Date
    April 25, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 07/23/2019. H3 DEVICE EVALUATION SUMMARY: TWO FAILED SUTURE NEEDLES, LABELED AS (B)(4), WERE IDENTIFIED AS PRODUCT CODE V371H FOR EVALUATION. A FRACTURE WAS OBSERVED AT THE TIP OF SAMPLE B. ONE SIDE OF THE NEEDLE WAS RECEIVED, THE MATING FRACTURE SURFACES WERE NOT PROVIDED FOR THIS EVALUATION. A SCANNING ELECTRON MICROSCOPE (SEM) WAS USED TO EXAMINE THE FRACTURE SURFACES AND SURROUNDING AREA OF THE NEEDLE. THE FRACTURE SURFACE WAS 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 MANUFACTURING RECORDS WERE REVIEWED, AND THE MANUFACTURING/PACKAGING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS BATCH. THE EVIDENCE OF THIS EXAMINATION INDICATES THAT THE BREAKAGE OCCURRED AT THE TIP 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. A SEALED (36 EA) BOX AND OPENED BOX WITH EIGHT REPRESENTATIVE SAMPLES OF PRODUCT CODE V371, LOT # PCBBSMR0 WAS RETURNED FOR ANALYSIS. AS TOTAL OF 44 SAMPLES. DURING THE VISUAL INSPECTION OF THIRTEEN UNOPENED SAMPLES, NO DEFECTS WERE FOUND ON THE PACKAGES. THE SAMPLES WERE OPENED, AND THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. NO NEEDLE BREAKAGE WAS OBSERVED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG OF THE STRAND AND NO DEFECTS WERE OBSERVED. ALSO, THE SAMPLES WERE TESTED BY RESISTANCE TEST TO NEEDLE AND MET THE REQUIREMENTS. THE MANUFACTURING RECORDS WERE REVIEWED, AND THE MANUFACTURING/ PACKAGING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS BATCH. PER THE CONDITIONS OF THE SAMPLES RECEIVED, NO PERFORMANCE BREAKAGE NEEDLE WERE FOUND. REPRESENTATIVE SAMPLES RETURNED TO SUPPORT INVESTIGATION OF 2 DEVICE ISSUES CAPTURED IN REPORTS MW 2210968-2019-81512 AND 2210968-2019-81513. ANALYSIS RESULTS HAVE BEEN INCLUDED IN FOLLOW-UP REPORTS FOR EACH.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PCBBSMR0 NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN GYNECOLOGICAL PROCEDURE ON UNKNOWN DATE AND SUTURE WAS USED. THE TIP OF THE NEEDLE BROKE OFF DURING USE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418524 1 90CM VICRYL VIOLET SUTURE SINGLE ARMED CTX M4 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. PCBBSMR0

    Patients

    Seq Age Sex Outcome Treatment
    1