BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1790948 · Received August 4, 2010

    Report

    Report Number
    2522801-2010-00019
    Event Type
    Other
    Date Received
    August 4, 2010
    Date of Event
    June 1, 2010
    Report Date
    August 4, 2010
    Manufacturer
    SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)
    Product Code
    GAM
    PMA / PMN Number
    K072028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT/CODE INFO WAS NOT PROVIDED. THEREFORE, THE EXP. DATE AND MFG. DATE ARE UNK. ADD'L ITEM REPORTED BY THIS CUSTOMER: #2 PDO, MODEL/CATALOG #: UNK, LOT #: UNK, EXPIRATION DATE: UNK, DEVICE MANUFACTURE DATE: UNK, 510(K) #: K051609. THE DEVICE WAS NOT RETURNED FOR EVAL. METHOD: THE DEVICE WAS NOT RETURNED FOR EVAL. NO PRODUCT EVAL CAN BE PERFORMED. RESULTS/CONCLUSION: THE DEVICE WAS NOT RETURNED FOR EVAL. NO PRODUCT EVAL CAN BE PERFORMED. W/O THE FINISHED GOOD LOT NUMBER, RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. IT IS UNCERTAIN IF THIS PT'S ELEVATED INR MAY HAVE CONTRIBUTED TO THIS EVENT. IT WAS NOT POSSIBLE TO DETERMINE THE RELATIVE CONTRIBUTION TO THE INCIDENT SINCE TWO DIFFERENT CLOSURE DEVICES WERE USED. ANGIOTECH REFERENCE: COMPLAINT (B)(4), ITEM # YA-1029Q / UNKNOWN, QUILL SRS, 0 MONODERM / #2 PDO, LOT UNKNOWN / UNKNOWN.

    Description of Event or Problem · 1

    THE DATE OF THE EVENT IS ESTIMATED. DR (B)(6) PERFORMED A TOTAL KNEE ARTHROPLASTY USING QUILL SRS #2 PDO FOR CAPSULAR CLOSURE, #1 VICRYL FOR FASCIAL CLOSURE, 0 MONODERM FOR DEEP DERMAL CLOSURE AND STAPLES FOR SKIN CLOSURE. APPROX SIX (6) WEEKS POST OPERATIVELY, PT PRESENTED WITH A WOUND DEHISCENCE OF THE DEEP DERMAL LAYER. WOUND WAS CLEANED OUT AND RE CLOSED WITH NYLON SUTURE. THE SURGEON STATED THAT THE PT'S INR WAS 14. HOWEVER, NO PARTICULAR EVENT OCCURRED SUCH AS A FALL THAT WOULD HAVE LED TO THE DEHISCENCE. IT WAS NOT POSSIBLE TO DETERMINE THE RELATIVE CONTRIBUTION TO THE INCIDENT SINCE TWO DIFFERENT CLOSURE DEVICES WERE USED. A RECENT META-ANALYSIS PUBLISHED IN BMJ STATES THAT "AFTER ORTHOPAEDIC SURGERY, THERE IS A GREATER RISK OF WOUND INFECTION IN PTS WHOSE WOUNDS ARE CLOSED WITH METALLIC STAPLES THAN WITH SUTURES" (SMITH, TO, BMJ 2010;340:C1199).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUILL SRS BARBED SUTURE AND NEEDLE GAM SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH) YA-1029Q UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention