BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1642761 · Received March 25, 2010

    Report

    Report Number
    2522801-2010-00007
    Event Type
    Other
    Date Received
    March 25, 2010
    Date of Event
    October 1, 2008
    Report Date
    March 25, 2010
    Manufacturer
    SURGICAL SPECIALTIES CORP (DBA ANGIOTECH)
    Product Code
    NEW
    PMA / PMN Number
    K051609
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES FROM THE REPORTED FINISHED GOOD LOT WERE RETURNED TO ANGIOTECH FOR EVALUATION. ONE (1) OTHER QUILL SRS PRODUCT WAS ALSO REPORTED. THE PRODUCT INFORMATION IS AS FOLLOWS: 2-0 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. SURGEON HAS SINCE CHANGED HIS CLOSURE TECHNIQUE USING QUILL SRS AND HAS HAD NO FURTHER ISSUES OF DEHISCENCE. IT IS UNCERTAIN IF PHYSICIANS PREVIOUS TECHNIQUE CONTRIBUTED TO THIS EVENT. (B)(4), ITEM # RA-1029Q, QUILL SRS, #2 PDO, LOT UNK. ITEM # UNK, QUILL SRS, 2-0 PDO, LOT UNK.

    Description of Event or Problem · 1

    THESE CASES OCCURRED 12-18 MONTHS AGO AND WERE NOT REPORTED BY THE PHYSICIAN. (B)(6), PHYSICIAN ASSISTANT AND CURRENT USER OF QUILL, PERFORMED THREE (3) TOTAL KNEE REPLACEMENTS WHERE QUILL SRS, #2 PDO WAS USED FOR CAPSULAR CLOSURE, VICRYL FOR INTERMEDIATE LAYER AND 2-0 PDO FOR SUPERFICIAL LAYER CLOSURE. ALL THREE (3) PATIENTS, EXPERIENCED DEHISCENCE WITHIN A FEW DAYS TO TWO (2) WEEKS POST OPERATIVELY AND WERE RETURNED TO THE OPERATING ROOM FOR SECONDARY CLOSURE. THE PATIENTS WERE ALL ELDERLY, WITH FRAGILE TISSUE BUT OTHERWISE NO KNOWN SIGNIFICANT MEDICAL HISTORY OR POSTOPERATIVE TRAUMA. SURGEON HAS SINCE CHANGED CLOSURE TECHNIQUE USING QUILL SRS AND HAS HAD NO FURTHER ISSUES OF DEHISCENCE. ALL PATIENTS HEALED WELL POST REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUILL SRS BARBED SUTURE WITH NEEDLE NEW SURGICAL SPECIALTIES CORP (DBA ANGIOTECH) RA-1029Q UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention