BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1790949 · Received August 4, 2010

    Report

    Report Number
    2522801-2010-00020
    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
    NEW
    PMA / PMN Number
    K072028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOTCODE INFO WAS NOT PROVIDED. THEREFORE, THE EXPIRATION DATE AND MFG DATE ARE UNK. ADD'L ITEM REPORTED BY THIS CUSTOMER: #2 PDO, MODEL/CATALOG #: UNKNOWN, LOT #: UNKNOWN, EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN, 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 COULD NOT BE REVIEWED. IT WAS NOT POSSIBLE TO DETERMINE THE RELATIVE CONTRIBUTION OF THE DEVICE 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" (B)(4). ITEM # YA-1029Q / UNKNOWN, QUILL SRS, 0 MONODERM / #2 PDO, LOT UNKNOWN / UNKNOWN.

    Description of Event or Problem · 1

    DR. (B)(6) PERFORMED A TOTAL HIP ARTHROPLASTY USING QUILL SRS #2 PDO FOR CAPSULE CLOSURE, QUILL SRS 0 MONODERM FOR DEEP DERMAL CLOSURE AND STAPLES FOR THE SKIN CLOSURE. APPROX TWO (2) WEEKS POST OPERATIVELY, STAPLES WERE REMOVED. APPROX TWO (2) WEEKS POST STAPLE REMOVAL, THE PT PRESENTED WITH A ONE (1) CM. WOUND DEHISCENCE. THE WOUND WAS DRAINED AND CLOSED USING DERMABOND. THE PT WAS PLACED ON ORAL ANTIBIOTICS. HOWEVER, NO CULTURE AND SENSITIVITIES WERE PERFORMED. THE SURGEON STATED THAT THE PT IS PROGRESSING WELL. IT WAS NOT POSSIBLE TO DETERMINE THE RELATIVE CONTRIBUTION OF THE DEVICE TO THE INCIDENT SINCE TWO DIFFERENT CLOSURE DEVICES WERE USED. A RECENT META-ANALYSIS PUBLISHED IN (B)(6) 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" (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention