BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910)

    MDR report key: 2992136 · Received March 7, 2013

    Report

    Report Number
    2210968-2013-02059
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 14, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: 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.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY EVALUATED. 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 NEEDLE 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 NEEDLE. A VISUAL INSPECTION WAS ALSO PERFORMED ON SEVEN NEEDLES RETURNED FOR EVALUATION. FOUR OF THE NEEDLES APPEAR TO HAVE BEEN USED, THE SUTURES WERE REMOVED AND THERE WERE INDENTS AND SCUFF MARKS ON THE NEEDLES, THE THREE ADDITIONAL NEEDLES WERE STILL PARKED IN THE NEEDLE TRAY WITH THE SUTURES STILL ATTACHED. THERE WERE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2013 AND SUTURE WAS USED. WHEN KNOTTING THE SUTURE AT THE EPIDERMIS THE NEEDLE BROKE NEAR THE SWAGE. THE FRAGMENT WAS REMOVED FROM THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97321 COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE ABSORBABLE GAM ETHICON, INC. NA EJ2402

    Patients

    Seq Age Sex Outcome Treatment
    1