BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1691564 · Received May 14, 2010

    Report

    Report Number
    2522801-2010-00011
    Event Type
    Other
    Date Received
    May 14, 2010
    Date of Event
    April 21, 2010
    Report Date
    May 14, 2010
    Manufacturer
    SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)
    Product Code
    NEW
    PMA / PMN Number
    K051609
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE RETURNED TO ANGIOTECH FOR EVALUATION. ONE (1) OTHER QUILL SRS PRODUCT WAS ALSO REPORTED. THE PRODUCT INFORMATION IS AS FOLLOWS: #0 POD MODEL/CATALOG #: RA-1029Q; LOT #: UNKNOWN; EXPIRATION DATE: UNKNOWN; DEVICE MANUFACTURE DATE: UNKNOWN; 510(K) #: K051609. METHOD: THE DEVICES WERE NOT RETURNED FOR EVALUATION. WITHOUT THE LOT CODE INFORMATION, RELEVANT PORTIONS OF THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. RESULTS/ CONCLUSION: THE DEVICES WERE NOT RETURNED FOR EVALUATION. NO PRODUCT EVALUATION CAN BE PERFORMED. IT IS UNCERTAIN WHAT TECHNIQUE WAS USED WHEN CLOSING THESE CASES. IT IS POSSIBLE THAT THE LACK OF PROPER TRAINING OF THE SURGEONS' ASSISTANTS CONTRIBUTED TO THIS EVENT. (B)(4); ITEM # RA-1067Q, QUILL SRS, #0 PD0, LOT UNKNOWN. ITEM # RA-1029Q, QUILL SRS, #0 PD0, LOT UNKNOWN.

    Description of Event or Problem · 1

    THE DATE OF THIS EVENT IS ESTIMATED: THE SURGEON REPORTED THAT TWO (2) PATIENTS EXPERIENCED WOUND DEHISCENCE OF THE INTERMEDIATE LAYER FOLLOWING A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE AND AN ANKLE PROCEDURE. IT IS UNKNOWN ON WHAT POST OPERATIVE DAY THE DEHISCENCE OCCURRED. QUILL SRS 0# PDO WAS USED IN BOTH OF THE PROCEDURES. HOWEVER, IT IS UNKNOWN WHAT TYPE OF TECHNIQUE WAS USED. THE SURGEON ALSO STATED THAT HE USES FOUR (4) ASSISTANTS TO CLOSE HIS CASES AND NOT ALL OF THESE ASSISTANTS WERE PROPERLY TRAINED IN THE USE OF QUILL SRS. SURGICAL INTERVENTION WAS REQUIRED FOR THE TKA PATIENT. THE ANKLE CASE WAS MONITORED WITH NO ADDITIONAL INTERVENTION REQUIRED. MULTIPLE ATTEMPTS WERE MADE TO REACH THE SURGEON TO ACQUIRE ADDITIONAL INFORMATION AND FURTHER CLARIFICATION OF THE CLINICAL DATA WITH NO SUCCESS.

    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-1067Q UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention