BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDS II (POLYDIOXANONE) SUTURE

    MDR report key: 1911378 · Received November 24, 2010

    Report

    Report Number
    2210968-2010-01597
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Report Date
    October 26, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: THE ACTUAL NEEDLE SHOWS A FRACTURE AT THE NEEDLE EYE IN THE AREA OF THE CHANNEL. DURING VISUAL INSPECTION UNDER A LIGHT - MICROSCOPE SEVERAL HEAVY MARKS OF NEEDLE HOLDER WERE FOUND IN THIS AREA, DIRECT AT THE BREAKING POINT AND AT THE NEEDLE POINT WHICH INDICATES THAT THE NEEDLE WAS HANDLED THERE. CONCLUSION: THE DEVICE INFO FOR USE CAUTIONS THAT USER THAT "TO AVOID DAMAGING THE NEEDLE POINTS AND SWAGE AREAS, GRASP THE NEEDLE IN AN AREA ONE THIRD TO ONE-HALF THE DISTANCE FROM THE SWAGED END TO THE POINT." IN ADDITION, A REVIEW OF THE BATCH MFG 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 ALSO MEDWATCH 2210968-2010-01610. THE SAME PT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A SURGICAL PROCEDURE ON AN UNK DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE AT THE ATTACHMENT ZONE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PDS II (POLYDIOXANONE) SUTURE SUTURE, ABSORBABLE NEW ETHICON, INC. NA CH8LCKQ0

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK