BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1730112 · Received June 18, 2010

    Report

    Report Number
    2522801-2010-00014
    Event Type
    Other
    Date Received
    June 18, 2010
    Date of Event
    May 1, 2010
    Report Date
    June 18, 2010
    Manufacturer
    SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)
    Product Code
    NEW
    PMA / PMN Number
    K051609
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE RETURNED TO ANGIOTECH FOR EVAL. TWO (2) OTHER QUILL SRS LOTS WERE REPORTED. THE PRODUCT INFO IS AS FOLLOWS: #2 PDO SUTURE - MODEL/CATALOG #: RA-1065Q, LOT#: M327870, EXPIRATION DATE: 01/31/2011, DEVICE MANUFACTURE DATE: 01/2010, 510(K)#: K051609; #2 PDO - MODEL/CATALOG#: RA-1065Q, LOT#: M353580, EXPIRATION DATE: 01/31/2011, DEVICE MANUFACTURE DATE: 01/2010, 510(K)#: K051609. METHOD: THE DEVICES WERE NOT RETURNED FOR EVAL. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORDS WERE REVIEWED. THERE WERE NO QUALITY ISSUES NOTED DURING THE MANUFACTURING PROCESSES OR AT FINAL RELEASE. THE STERILITY REQUIREMENTS WERE WITHIN SPECIFICATION. THERE WERE NO OTHER COMPLAINTS RECEIVED FOR ANY OF THE REPORTED FINISHED GOOD LOTS. RESULTS/CONCLUSION: THE DEVICES WERE NOT RETURNED FOR EVAL. NO PRODUCT EVAL CAN BE PERFORMED. (B)(4), ITEM# RA-1065Q, QUILL SRS, #2 PDO, LOT M347670, M327670, M353580.

    Description of Event or Problem · 1

    THE DATE OF THE EVENT IS ESTIMATED. A SURGEON FROM (B)(6) REPORTED MULTIPLE CASES OF SUTURE RUPTURE AND REACTIONS POST-OPERATIVE PROCEDURES PERFORMED USING QUILL SRS PDO SUTURE. IT IS UNCLEAR IF THESE ARE STERILE REACTIONS TO A POLYMER OR INFECTION IN HIP AND KNEE ARTHROPLASTIES. THE EXACT TYPE OF REACTION HAS NOT BEEN VERIFIED. NO CULTURE AND SENSITIVITIES WERE PERFORMED. QUILL SRS #2 PDO WAS USED FOR CAPSULAR CLOSURE, VICRYL TO CLOSE THE SUBCUTICULAR LAYER AND STAPLES FOR SKIN CLOSURE. PTS WERE TAKEN BACK TO THE OPERATING ROOM FOR REPAIR OF THE CAPSULAR DEHISCENCE. THE SURGEON STAPLES THAT ONE (1) PT EXPERIENCED A FALL POST OPERATIVELY AND ANOTHER PT MAY HAVE HAD TOO AGGRESSIVE PHYSICAL THERAPY ON POST OPERATIVE DAY NUMBER ONE (1). IT IS UNK IF ANY OF THESE PTS HAD ANY HEALTH RELATED ISSUES THAT MAY HAVE AFFECTED THE HEALING PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUILL SRS BARBED SUTURE AND NEEDLE NEW SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH) RA-1065Q M347670

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention