BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1649733 · Received April 1, 2010

    Report

    Report Number
    2522801-2010-00008
    Event Type
    Other
    Date Received
    April 1, 2010
    Date of Event
    December 1, 2009
    Report Date
    April 1, 2010
    Manufacturer
    SURGICAL SPECIALTIES CORP (DBA ANGIOTECH)
    Product Code
    NEW
    PMA / PMN Number
    K051609
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES FROM THE REPORTED FINISHED GOOD LOT WERE RETURNED TO ANGIOTECH FOR EVALUATION. THE ITEM NUMBER AND LOT CODE INFORMATION WAS NOT DISCLOSED. THEREFORE, THE EXPIRATION AND MANUFACTURING DATE IS UNKNOWN. METHOD: THE DEVICE WAS NOT RETURNED FOR EVALUATION. FURTHERMORE, WITHOUT THE LOT CODE INFORMATION, RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. RESULTS / CONCLUSION: THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO PRODUCT EVALUATION CAN BE PERFORMED. IT IS NOT CERTAIN IF THE SURGEON'S PLACEMENT OF THE PDO SUTURE LED TO THE STITCH ABSCESSES. HE IS NOW USING 3-0 MONODERM FOR SUPERFICIAL LAYER CLOSURE AND HAS EXPERIENCED NO FURTHER ISSUES. (B)(4), ITEM # UNK, QUILL SRS, #2 PDO, LOT UNK, ITEM # UNK, QUILL SRS, 2-0 PDO, LOT UNK, ITEM # UNK, QUILL SRS, 3-0 PDO, LOT UNK.

    Description of Event or Problem · 1

    THESE CASES OCCURRED THROUGHOUT 2009 AND WERE NOT REPORTED BY THE PHYSICIAN UNTIL 03/11/2010. DR. (B)(6) REPORTED THAT HE PERFORMED MULTIPLE TOTAL KNEE ARTHROPLASTY PROCEDURES WHERE QUILL SRS SUTURE WAS USED. NUMBER 2 PDO WAS USED FOR CAPSULAR CLOSURE, VICRYL FOR INTERMEDIATE LAYER CLOSURE AND 2-0 PDO OR 3-0 PDO FOR SUPERFICIAL LAYER CLOSURE. THE PATIENTS PRESENTED POST-OPERATIVELY WITH STITCH ABSCESSES. AN UNKNOWN NUMBER OF THESE PATIENTS SUBSEQUENTLY OPENED APPROXIMATELY 1CM AND WERE TREATED AGGRESSIVELY WITH RE-OPERATION FOR IRRIGATION AND EMPIRICAL ANTIBIOTICS. NO CULTURES WERE TAKEN. THE SURGEON STATED THAT HE FEELS THAT HE MAY HAVE PLACED THE PDO TOO SUPERFICIALLY WHICH LED TO THESE STITCH ABSCESSES. HE HAS SINCE SWITCHED TO USING 3-0 MONODERM FOR SUPERFICIAL LAYER CLOSURE AND HAS EXPERIENCED NO FURTHER ISSUES.

    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