BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIXT DEKLENE SUTURE

    MDR report key: 3010852 · Received March 14, 2013

    Report

    Report Number
    1018233-2013-00851
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 20, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAL
    PMA / PMN Number
    K930738
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT IS INCONCLUSIVE DUE TO PARTIAL SAMPLE RETURN. RECEIVED NEEDLE WITH A PARTIAL PIECE OF SUTURE APPROXIMATELY 3 1/4" LONG WITH ORIGINAL PRODUCT LABELING. THE BULLET AND THE BULLET END OF THE SUTURE WERE NOT RETURNED WITH THE SAMPLE. IT WAS NOTED THAT THE NEEDLE WAS BROKEN UPON RETURN OF THE SAMPLE; APPROXIMATELY 0.2CM OF THE NEEDLE WAS STILL ATTACHED TO THE SUTURE. THE EXACT CAUSE OF THE BROKEN NEEDLE COULD NOT BE DETERMINED, HOWEVER, IT WOULD NOT HAVE CONTRIBUTED TO THE SEPARATION OF THE BULLET FROM THE SUTURE. THE FINISHED PRODUCT MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED FOR GENERAL DISTRIBUTION. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. THE INSTRUCTIONS FOR USE STATES IN THE PRECAUTIONS: "AVOID EXCESSIVE HANDLING I.E. CRUSHING OR CRIMPING RESULTING FROM USE OF SURGICAL INSTRUMENTS SUCH AS FORCEPS AND NEEDLE HOLDERS. ADEQUATE KNOT SECURITY REQUIRES THE ACCEPTED SURGICAL TECHNIQUE OF FLAT, SQUARE TIRES, WITH ADDITIONAL THROWS AS WARRANTED BY SURGICAL CIRCUMSTANCE AND THE EXPERIENCE OF THE SURGEON. THE USE OF ADDITIONAL THROWS MAY BE PARTICULARLY APPROPRIATE WHEN KNOTTING MONOFILAMENTS. STRONG FAMILIARITY WITH SURGICAL PROCEDURES AND TECHNIQUES FOR NONABSORBABLE SUTURES IS REQUIRED BEFORE USE." (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE DOCTOR TRIED TO FASTEN THE SUTURE INTO THE DEVICE, THE BULLET FELL OFF THE SUTURE. THE DOCTOR HAS BEEN USING THIS DEVICE FOR A LONG TIME AND THEREFORE WAS CAREFUL TO NOT PULL TOO HARD ON THE SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108228 FIXT DEKLENE SUTURE GAL TELEFLEX MEDICAL NA 02F1103016

    Patients

    Seq Age Sex Outcome Treatment
    1