BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1642763 · Received March 25, 2010

    Report

    Report Number
    2522801-2010-00006
    Event Type
    Other
    Date Received
    March 25, 2010
    Date of Event
    March 9, 2010
    Report Date
    March 25, 2010
    Manufacturer
    SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)
    Product Code
    NEW
    PMA / PMN Number
    K072028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THE EVENT IS ESTIMATED. NO SAMPLES FROM THE REPORTED FINISHED GOOD LOT WERE RETURNED TO ANGIOTECH FOR EVALUATION. ONE (1) OTHER QUILL SRS PRODUCTS WAS ALSO REPORTED. THE PRODUCT INFORMATION IS AS FOLLOWS: #2 PDO. MODEL/CATALOG #: UNK, LOT #: UNK, EXPIRATION DATE: UNK, DEVICE MANUFACTURE DATE: UNK 510(K)#: K051609. 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 UNCERTAIN IF PHYSICIANS DECISION TO USE STERI-STRIPS INSTEAD OF THE STAPLES, AS TYPICALLY USED, CONTRIBUTED TO THIS EVENT. (B)(4), ITEM # YA-1024Q, QUILL SRS, 2-0 MONODERM, LOT UNK. ITEM # UNK, QUILL SRS, #2 PDO, LOT UNK.

    Description of Event or Problem · 1

    THE DATE OF THIS EVENT IS ESTIMATED: (B)(6) PERFORMED A TOTAL KNEE ARTHROPLASTY PROCEDURE USING QUILL SRS, FOR THE FIRST TIME. HE USED #2 PDO FOR CAPSULAR CLOSURE, AND 2-0 MONODERM FOR THE SUBCUTICULAR LAYER. THE SURGEON ELECTED TO USE STERI-STRIPS FOR THE SKIN AS OPPOSED TO STAPLES, WHICH IS WHAT HE TYPICALLY USED HISTORICALLY. PATIENT EXPERIENCED A COMPLETE DEHISCENCE ON POST OPERATIVE DAY ONE (1) AND WAS TAKEN BACK TO THE OPERATING ROOM FOR IRRIGATION AND CLOSURE. IN SURGEON'S PREVIOUS CASES, CLOSURE WAS DONE USING QUILL SRS, #2 PDO FOR CAPSULE, 2-0 MONODERM FOR SUBCUTICULAR AND STAPLES FOR SKIN WITH NO POST OPERATIVE 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) YA-1024Q UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention