BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SUTURE PRODUCT

    MDR report key: 1736558 · Received June 17, 2010

    Report

    Report Number
    2210968-2010-00690
    Event Type
    Malfunction
    Date Received
    June 17, 2010
    Date of Event
    May 18, 2010
    Report Date
    May 19, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAK
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    *

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS: A NEEDLE THAT BROKE AT THE POINT WAS SUBMITTED FOR THIS EVALUATION. A MICROSCOPIC INSPECTION 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. CONCLUSION: THE DEVICE INFORMATION FOR USE CAUTIONS THE 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. CARE SHOULD BE TAKEN TO AVOID DAMAGE FROM HANDLING. AVOID CRUSHING OR CRIMPING DAMAGE DUE TO APPLICATION OF SURGICAL INSTRUMENTS SUCH AS FORCEPS OR NEEDLE HOLDERS". IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE PDS II SUTURE POSSIBLE BATCH NUMBER WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165543 UNKNOWN SUTURE PRODUCT SUTURE, ABSORBABLE GAK ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown