BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL STAINLESS STEEL SUTURE

    MDR report key: 3021784 · Received March 26, 2013

    Report

    Report Number
    2210968-2013-02807
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 3, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    GAQ
    PMA / PMN Number
    K946173
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION OF THE SCANNING ELECTRON MICROSCOPE (SEM) PHOTOS WAS PERFORMED WHICH REVEALED INDENTS AND SCUFF MARKS AROUND THE BREAK AREA PRODUCED DURING HANDLING BY A SURGICAL NEEDLE HOLDERS OR SOME OTHER GRIPPING DEVISE. THE NEEDLES FRACTURED DUE TO TENSILE OVERLOAD GENERATED DURING SEVERE MECHANICAL DEFORMATION, WITH SIGNS OF DUCTILE FAILURE. THERE ARE NO SIGNS OF MANUFACTURING DEFECTS FOUND ON THE NEEDLES. IN ORDER TO AVOID THIS KIND OF DAMAGE THE PACKAGE INSERT CAUTIONS: 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.

    Additional Manufacturer Narrative · 1

    (B)(4): THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 2210968-2013-02806. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE FOR CONSTRICTIVE PERICARDITIS ON (B)(6) 2013 AND SUTURE WAS USED. WHEN THE SURGEON WAS STITCHING THE STERNUM, THE NEEDLE TIP BROKE. THE SURGEON COULD NOT FIND THE NEEDLEPOINT. CHANGED THE SECOND ONE TO CONTINUE THE PROCEDURE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124758 SURGICAL STAINLESS STEEL SUTURE SUTURE, NON-ABSORBABLE GAQ ETHICON, INC. NA EDE203

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other