BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOCRYL PLUS ANTIBACTERIAL SUTURES

    MDR report key: 2252020 · Received September 16, 2011

    Report

    Report Number
    2210968-2011-01305
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 19, 2011
    Report Date
    August 23, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    GAN
    PMA / PMN Number
    K050845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE ACTUAL NEEDLE REVEALED INDENTS AND SCUFF MARKS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LACERATION CLOSURE PROCEDURE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE BROKE DURING USE AND THE NEEDLE PIECES WERE REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOCRYL PLUS ANTIBACTERIAL SUTURES SUTURE, ABSORBABLE GAN ETHICON, INC. NA DBK001

    Patients

    Seq Age Sex Outcome Treatment
    1