BEUDAMED
    FDA Adverse Event Other Summary report: N

    SHARPOINT

    MDR report key: 829298 · Received February 20, 2007

    Report

    Report Number
    2522801-2007-00002
    Event Type
    Other
    Date Received
    February 20, 2007
    Report Date
    February 19, 2007
    Manufacturer
    SURGICAL SPECIALTIES CORP (ANGIOTECH)
    Product Code
    GAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WITHIN THE "PRECAUTIONS" SECTION OF THE IFU FOR THIS TYPE OF SUTURE MATERIAL, IT STATES "IN HANDLING THIS OR ANY OTHER SUTURE MATERIAL, 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. AS WITH ANY SUTURE MATERIAL, ADEQUATE KNOT SECURITY REQUIRES THE ACCEPTED SURGICAL TECHNIQUE OF FLAT, SQUARE TIES, 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". THE DR'S ASSISTANT DID NOT PROVIDE INFO ON THE DR'S KNOT TECHNIQUE OR THE TYPE OF STITCH USED TO APPROXIMATE THE INCISION. EVALUATION OF DEVICE SUMMARY: ON 02/19/2007 - SAMPLES OF ITEM AA-2516N WHICH WERE MANUFACTURED USING THE SAME LOT OF RAW SUTURE MATERIAL WERE PULLED FROM STOCK FOR EVALUATION. A VISUAL EVALUATION, U.S.P. DIMENSION AND STRAIGHT PULL TEST WERE PERFORMED ON TEN (10) PIECES. ALL SAMPLES WERE NOTED TO HAVE NO IRREGULARITIES AND THE RESULTS OF THE TESTS PERFORMED WERE ACCEPTABLE AND MET THE CURRENT U.S.P. AND ANGIOTECH SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 1

    INDEPENDENT REP REPORTED ON 01/22/2007, THE DR (OPHTHALMOLOGIST) WAS EXPERIENCING BREAKAGE DURING USE WITH 10/0 BLACK MONOFILAMENT NYLON SUTURE (ITEM #AA-2675N - LOT #M036550) AND ALSO REPORTED ONE (1) INCIDENT WHERE A PT RETURNED TWO (2) TO THREE (3) WEEKS POST-OP WITH BROKEN SUTURES IN THE EYE WHICH RESULTED IN RE-SUTURE AND TREATMENT WITH ANTIBIOTICS FOR AN INFECTION. INDEPENDENT REP REPORTED THAT THE PT HAS SINCE RECOVERED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHARPOINT SUTURE AND NEEDLE GAR SURGICAL SPECIALTIES CORP (ANGIOTECH) AA-2675N M036550

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention