BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUILL SRS

    MDR report key: 1148023 · Received September 3, 2008

    Report

    Report Number
    2522801-2008-00028
    Event Type
    Malfunction
    Date Received
    September 3, 2008
    Date of Event
    July 1, 2008
    Report Date
    September 3, 2008
    Manufacturer
    SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)
    Product Code
    NEW
    PMA / PMN Number
    K051609
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF EVENT IS ESTIMATED. THE IMPLANT DATE(S) ARE ESTIMATED AS (B)(6) 2008. A SECOND DEVICE WAS ALSO REPORTED. THE PRODUCT INFORMATION IS AS FOLLOWS: MODEL/CATALOG #: YA-1015Q, LOT #: M376460, EXPIRATION DATE: 04/30/2010, DEVICE MANUFACTURE DATE: 04/2008, 510(K) #: K072028. ALL OTHER PRODUCT INFO RECORDED ON THIS FORM IS APPLICABLE TO BOTH DEVICES. METHOD: THE DEVICE WAS NOT RETURNED FOR EVALUATION. RESULTS: THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO PRODUCT EVALUATION CAN BE PERFORMED. CONCLUSIONS: RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD WERE REVIEWED FOR THE TWO (2) FINISHED GOOD LOT NUMBERS REPORTED. NO RELEVANT FINDINGS WERE NOTED DURING THIS REVIEW. ANGIOTECH REFERENCE: (B)(4).

    Description of Event or Problem · 1

    MULTIPLE PATIENTS UNDERWENT KNEE ARTHROPLASTY USING QUILL SRS SUTURES (SIZE 0, PDO FOR SUBCUTANEOUS CLOSURE AND SIZE 2-0, MONODERM FOR SUBCUTICULAR CLOSURE). THE PRODUCTS WERE PLACED WITH THE KNEE IN EXTENSION. AFTER FLEXION OF THE KNEE, FOR STRENGTH TESTING, THE PRODUCTS BROKE. THE DOCTORS WERE ABLE TO REINFORCE THE WOUNDS USING OTHER PRODUCTS. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUILL SRS BARBED SUTURE AND NEEDLE NEW SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH) RA-1030Q M316960

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NONE MADE AVAILABLE.