BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1661748 · Received April 19, 2010

    Report

    Report Number
    2522801-2010-00010
    Event Type
    Other
    Date Received
    April 19, 2010
    Date of Event
    March 24, 2010
    Report Date
    April 16, 2010
    Manufacturer
    SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)
    Product Code
    NEW
    PMA / PMN Number
    K051609
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE RETURNED TO ANGIOTECH FOR EVAL. TWO (2) OTHER QUILL SRS PRODUCTS WERE ALSO REPORTED. THE PRODUCT INFO IS AS FOLLOWS: # 0 PDO - MODEL/CATALOG #: RA-1067Q, LOT #: M704930, EXP DATE: 07/31/2011, DEVICE MANUFACTURE DATE: 07/2009, 510(K) #: K051609; 2-0 MONODERM- MODEL/CATALOG #: YA-1024Q, LOT #: M648710, EXP DATE: 05/31/2011, DEVICE MFR DATE: 05/2009, 510(K): K072028. METHOD: THE DEVICES WERE NOT RETURNED FOR EVAL. RESULTS/CONCLUSION: THE DEVICES WERE NOT RETURNED FOR EVAL. NO PRODUCT EVAL CAN BE PERFORMED. IT IS UNCERTAIN IF THE SURGEON'S DECISION TO USE THE MONODERM SUTURE FOR SKIN CLOSURE INSTEAD OF THE STAPLES, AS TYPICALLY USED HISTORICALLY, CONTRIBUTED TO THIS EVENT. ANGIOTECH REFERENCE: (B)(4). ITEM # RA-1067Q, QUILL SRS, # 0 PDO, LOT M704930, ITEM # YA-1024Q, QUILL SRS, 2-0 MONODERM, LOT M648710.

    Description of Event or Problem · 1

    THE DATE OF THIS EVENT IS ESTIMATED. (B)(6) PERFORMED A TOTAL KNEE ARTHROPLASTY PROCEDURE USING QUILL SRS #2 PDO FOR CAPSULAR CLOSURE, 0 PDO FOR THE INTERMEDIATE LAYER AND 2-0 MONODERM FOR SKIN CLOSURE. PER THIS ACCOUNT'S SALES REP, THIS SURGEON TYPICALLY CLOSES THE SKIN WITH STAPLES. HOWEVER, DURING THIS CASE, THE SURGEON ALLOWED THE RESIDENT TO CLOSE THE SKIN USING THE MONODERM SUTURE. THE PT EXPERIENCED DEHISCENCE APPROX TWO (2) WEEKS POST-OPERATIVELY. IT IS UNK WHAT LAYER OF CLOSURE DEHISCED DUE TO THE INABILITY TO REACH SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUILL SRS BARBED SUTURE WITH NEEDLE NEW SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH) RA-1065Q M283780

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention