BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN SURGICAL SUTURE

    MDR report key: 1068041 · Received July 2, 2008

    Report

    Report Number
    2522801-2008-00020
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    June 5, 2008
    Report Date
    July 1, 2008
    Manufacturer
    SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)
    Product Code
    GAW
    PMA / PMN Number
    K926168
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SECOND PRODUCT WAS ALSO REPORTED. THE PRODUCT INFO IS AS FOLLOWS: MODEL/CATALOG#: 101-2590. LOT#: M071220. EXP DATE: 12/31/2011. DEVICE MANUFACTURE DATE: 12/06. ALL OTHER INFO RECORDED ON THIS FORM IS APPLICABLE TO BOTH PRODUCTS. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE PRODUCT MET SPECIFICATION THROUGHOUT MANUFACTURING. NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR PRODUCT, LOT M183330 OR LOT M071220. ANALYSIS OF THE RETURNED SAMPLE SHOWS THAT THE NEEDLE FAILED AT THE SWAGED AREA. THE FAILURE MODE WAS DUPLICATED BY GRIPPING THE SWAGED AREA OF A SIMILAR NEEDLE FROM STOCK WITH FORCEPS. A LOAD WAS APPLIED AT THE TIP OF THE NEEDLE. THE NEEDLE BENDS AND ULTIMATELY FAILS AT THE CLAMPED AREA. THE SAME TEST WAS REPEATED BY GRIPPING THE NEEDLE ABOVE THE SWAGED AREA. IN THESE TESTS, THE NEEDLE BENDS BUT DOES NOT FAIL. IN CONCLUSION, THESE FINDINGS APPEAR TO INDICATE THAT THE NEEDLE FAILURE IS RELATED TO THE TECHNIQUE OF THE END-USER. WHEN THE NEEDLE IS GRIPPED IN THE SWAGED AREA, THE STRESS, OR POUNDS PER SQUARE INCH, AT THIS GRIPPED AREA MAY EXCEED THE MAXIMUM STRESS OF THE MATERIAL THUS RESULTING IN A FAILURE (I.E. BROKEN NEEDLE). THE STRESS IS REDUCED WHEN THE NEEDLE IS HELD ABOVE THE SWAGED AREA, THUS ALLOWING THE NEEDLE TO BEND INSTEAD OF BREAK. THIS INCIDENT WAS INITIALLY REPORTED TO THE DISTRIBUTOR OF THE PRODUCT. DISTRIBUTOR THEN NOTIFIED ANGIOTECH. ANGIOTECH REFERENCE: (4-0 BLACK BRAIDED SILK, 18 INCHES).

    Description of Event or Problem · 1

    A NEEDLE "BROKE" IN A PT'S MOUTH DURING A SUTURING PROCEDURE. THERE WAS NO PT INJURY AND ALL OF THE NEEDLE WAS ACCOUNTED FOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HENRY SCHEIN SURGICAL SUTURE SUTURE AND NEEDLE GAW SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH) 101-2590 M183330

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NONE MADE AVAILABLE