BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 3060245 · Received April 16, 2013

    Report

    Report Number
    2210968-2013-03960
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Adverse Event
    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 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. THE DEVICE INFORMATION FOR USE CAUTIONS THE USER THAT "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 A BUTTOCK SKIN TUMOR REMOVAL PROCEDURE ON (B)(6) 2013 AND SUTURE WAS USED. AFTER SUTURING THE FASCIA, THE NEEDLE BROKE AT THE BODY DURING KNOTTED SUTURING OF THE FAT AND FELL INTO THE PATIENT. THE NEEDLE WAS FOUND AND REMOVED FROM THE FAT TISSUE AFTER THE SUTURE WAS REMOVED AND A LITTLE BIT OF FAT WAS REMOVED. THE SURGERY WAS THEN COMPLETED SUCCESSFULLY. THE PATIENT WAS STILL HOSPITALIZED AND IS GETTING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163491 COATED VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA CJ2267

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention