BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDS II PLUS ANTIBACTERIAL SUTURE

    MDR report key: 1203305 · Received October 14, 2008

    Report

    Report Number
    2210968-2008-00998
    Event Type
    Malfunction
    Date Received
    October 14, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 4, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    GAK
    PMA / PMN Number
    K061037
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. THE NEEDLE WAS VISUALLY EXAMINED USING A SCANNING ELECTRON MICROSCOPE (SEM). THE NEEDLE BROKE AT THE TIP. SCUFF MARKS AND INDENTS ARE OBSERVED AROUND THE BREAK AREA PRODUCED DURING HANDLING BY THE SURGICAL NEEDLE HOLDERS OR SOME OTHER GRIPPING DEVICE. 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. CONCLUSION: USER ERROR CAUSED THE EVENT. THE PACKAGE INSERT CAUTIONS: TO AVOID DAMAGING NEEDLE POINTS AND SWAGE AREAS, GRASP THE NEEDLE IN THE 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

    CUSTOMER REPORTED THAT THE NEEDLE TIP BROKE OFF DURING A VAGINAL HYSTERECTOMY PROCEDURE. THE NEEDLE WAS RECOVERED IN THE SAME PROCEDURE. NO ADVERSE PT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PDS II PLUS ANTIBACTERIAL SUTURE SUTURES, ABSORBABLE GAK ETHICON, INC. NA ZLK435

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR