BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL KNOTLESS TISSUE CLOSURE DEVICE

    MDR report key: 2724957 · Received August 29, 2012

    Report

    Report Number
    3008845715-2012-00004
    Event Type
    Other
    Date Received
    August 29, 2012
    Report Date
    August 27, 2012
    Manufacturer
    SURGICAL SPECIALTIES PUERTO RICO INC. DBA ANGIOTECH
    Product Code
    NEW
    PMA / PMN Number
    K051609
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS MOMENT, SAMPLES HAVE NOT BEEN RETURNED TO SURGICAL SPECIALTIES PUERTO RICO INC DBA ANGIOTECH FOR EVALUATION. METHOD - AT THIS MOMENT, SAMPLES HAVE NOT BEEN RETURNED TO SURGICAL SPECIALTIES PUERTO RICO INC DBA ANGIOTECH FOR EVALUATION. RESULTS/CONCLUSIONS: AT THIS MOMENT, SAMPLES HAVE NOT BEEN RETURNED TO SURGICAL SPECIALTIES PUERTO RICO INC DBA ANGIOTECH FOR EVALUATION. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD WERE REVIEWED FOR CORRESPONDING ISSUES IDENTIFIED DURING THE MANUFACTURING PROCESS OR AT FINAL INSPECTION. FINISHED GOOD PRODUCT WAS RECEIVED INTO INVENTORY WITHOUT QUALITY ISSUES. IT IS NOT CERTAIN IF LOT MQ03080 WAS USED FOR THIS SPECIFIC PT. LOT NUMBER HAS NOT BEEN CONFIRMED. (B)(4), ITEM #(B)(4), QUILL KNOTLESS TISSUE CLOSURE DEVICE 2HR36 #2 PDO 36 X 36, LOT MQ03080.

    Description of Event or Problem · 1

    BILATERAL TKA PROCEDURE USING QUILL 2-O PDO FOR CAPSULAR CLOSURE. TWO WEEKS POST PROCEDURE, WHILE IN A REHAB SESSION, PT EXPERIENCED A POPPING SENSATION. TWO WEEKS LATER, WHILE CLIMBING THE STAIRS AT HOME, PT EXPERIENCED A SECOND POPPING SENSATION. PT WAS RE-OPENED IN THE OPERATING ROOM AND IT WAS FOUND THAT THE QUILL MATERIAL WAS BROKEN. AT THAT TIME, IT WAS ALSO NOTED THAT THE #1 VICRYL PRODUCT THAT WAS USED WAS ALSO BROKEN. THIS PT WAS MORBIDLY OBESE, HAD SUFFERED A KNEE DISLOCATION PRIOR TO SURGERY, AND HER KNEES WERE VALGUS. PT IS HEALING WELL WITH NO FURTHER COMPLICATIONS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUILL KNOTLESS TISSUE CLOSURE DEVICE BARBED MATERIAL/NEEDLES NEW SURGICAL SPECIALTIES PUERTO RICO INC. DBA ANGIOTECH RX-1062Q MQ03080

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention NONE MADE AVAILABLE