BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1635483 · Received March 15, 2010

    Report

    Report Number
    2522801-2010-00003
    Event Type
    Other
    Date Received
    March 15, 2010
    Date of Event
    March 2, 2010
    Report Date
    March 12, 2010
    Manufacturer
    SURGICAL SPECIALTIES CORP (DBA ANGIOTECH)
    Product Code
    NEW
    PMA / PMN Number
    K051609
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NONE OF THE DEVICES WERE RETURNED FOR EVAL. ONE (1) OTHER QUILL SRS PRODUCTS WAS ALSO REPORTED. THE PRODUCT INFO IS AS FOLLOWS: 3-0 MONODERM; MODEL/CATALOG #: UNK; LOT #: UNK; EXP DATE: UNK; DEVICE MFR DATE: UNK; 510(K) #: K072028. METHOD: NONE OF THE DEVICES WERE RETURNED FOR EVAL. FURTHERMORE, RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED BECAUSE THE ITEM AND LOT CODE INFO WAS REPORTED AS "UNKNOWN". RESULTS/CONCLUSION: NONE OF THE DEVICES WERE RETURNED FOR EVAL. NO PRODUCT EVALS COULD BE PERFORMED. IT IS RECOMMENDED THAT A BACKSTITCH BE COMPLETED WHEN USING QUILL SRS PRODUCT. IT IS UNCERTAIN IF A BACKSTITCH WAS USED DURING THE INITIAL PROCEDURE, POSSIBLY CONTRIBUTING TO THIS EVENT. (B)(4). ITEM # UNK, QUILL SRS, #2 PDO, 3-0 MONODERM, LOT UNK.

    Description of Event or Problem · 1

    DR (B)(6) PERFORMED A TOTAL KNEE ARTHROPLASTY PROCEDURE USING QUILL SRS #2 PDO TO CLOSE THE CAPSULE, #1 PDO TO CLOSE THE INTERMEDIATE LAYER, 3-0 MONODERM TO CLOSE THE SUBCUTICULAR LAYER AND STAPLES TO CLOSE THE SKIN. AT 2 1/2 WEEKS POST OPERATIVE, THE PT WAS TAKEN BACK TO THE OPERATING ROOM WITH A DEHISCENCE OF THE CAPSULE AND SUBCUTICULAR LAYER. IT IS UNK IF THE SURGEON PLACED A RECOMMENDED BACKSTITCH DURING THE ORIGINAL PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention