BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUILL SRS

    MDR report key: 1355815 · Received April 3, 2009

    Report

    Report Number
    2522801-2009-00007
    Event Type
    Injury
    Date Received
    April 3, 2009
    Date of Event
    January 1, 2009
    Report Date
    April 3, 2009
    Manufacturer
    SURGICAL SPECIALTIES CORP.
    Product Code
    NEW
    PMA / PMN Number
    K051609
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THREE (3) LOT NUMBERS WERE REPORTED FOR THE MODEL NUMBER: LOT#: M334370, MFR DATE: 3/2008, EXP DATE: 3/2010, LOT#: M360690, MFR DATE: 3/2008, EXP DATE: 3/2010. AS OF THE DATE OF THIS REPORT, THE SURGICAL SPECIALITIES FACILITY IN READING, PA HAS NOT RECEIVED ANY COMPLAINT PRODUCT FOR EVALUATION. COMPLAINT PRODUCT HAS NOT BEEN RECEIVED FOR EVALUATION. NO PRODUCT EVALUATION CAN BE PERFORMED. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD (DHR) WERE REVIEWED FOR THE FINISHED GOOD LOT NUMBERS REPORTED. NO RELEVANT FINDINGS WERE NOTED DURING THIS REVIEW. RESULTS/CONCLUSIONS: COMPLAINT PRODUCT HAS NOT BEEN RECEIVED FOR EVALUATION. A REVIEW OF THE DHR YIELDED NO RELEVANT FINDINGS. FURTHERMORE, AS DESCRIBED, THE USER'S TECHNIQUE WAS NO CONGRUENT WITH THE QUILL SRS INSTRUCTIONS FOR USE (IFU), WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. DR WAS SENT INFORMATION WHICH ILLUSTRATES THE PROPER TECHNIQUE FOR USING THE QUILL SRS.

    Description of Event or Problem · 1

    QUILL SRS WAS USED IN (7) TOTAL HIP ARTHROPLASTY PROCEDURES. THE SURGEON PERFORMED A DUAL LAYER CLOSURE OF THE CAPSULE AND INTERMEDIATE LAYERS. THE SURGEON STATED THAT FOR PURPOSES OF WOUND SECURITY, HE TIED KNOTS IN THE PRODUCT INSTEAD OF TAKING THE RECOMMENDED BACKSTITCH TO LOCK THE DEVICE IN PLACE. THIS PRACTICE CONTRADICTS THE PRECAUTIONS STATED IN THE INSTRUCTIONS FOR USE (IFU), WHICH INDICATE THAT "TYING OF KNOTS IN QUILL SRS WILL DAMAGED THE BARBS AND POTENTIALLY REDUCE THEIR EFFECTIVENESS..." ADDITIONALLY, THE IFU STATES THAT "A BACKSTITCH OR BITE OF TISSUE LATERAL TO THE END OF THE INCISION IS REQUIRE TO LOCK THE DEVICE IN PLACE..." APPROXIMATELY TWO (2) TO THREE (3) WEEKS POST SURGERY, THE PATIENTS DEVELOPED HEMATOMAS AND DEHISCENCE WHICH REQUIRED SURGICAL INTERVENTION FOR DRAINAGE AND SECONDARY CLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUILL SRS BARBED SUTURE WITH NEEDLE NEW SURGICAL SPECIALTIES CORP. RA-1031Q M262850

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NONE MADE AVAILABLE