BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 3487769 · Received November 8, 2013

    Report

    Report Number
    2522801-2013-00003
    Event Type
    Other
    Date Received
    November 8, 2013
    Date of Event
    September 18, 2013
    Report Date
    November 11, 2013
    Manufacturer
    SURGICAL SPECIALTIES CORP.
    Product Code
    NEW
    PMA / PMN Number
    K123836
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE AVAILABLE FOR EVALUATION. THEREFORE, NO TESTING CAN BE PERFORMED. METHOD: NO SAMPLES WERE AVAILABLE FOR EVALUATION. THEREFORE, NO TESTING CAN BE PERFORMED. RESULTS/CONCLUSION: WITHOUT RETURNED SAMPLES, AN EVALUATION COULD NOT BE PERFORMED. FURTHERMORE, RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD WERE REVIEWED AND THERE WERE NO CORRESPONDING ISSUES IDENTIFIED DURING THE INCOMING, MANUFACTURING OR FINAL INSPECTION PROCESSES FOR THIS LOT OR ANY OF THE COMPONENTS. TO DATE, NO OTHER COMPLAINTS FOR THIS FINISHED GOOD LOT HAVE BEEN RECEIVED FROM THIS FACILITY OR ANY OTHER END-USERS. PER THE SURGEON'S COMMENTS, IT'S POSSIBLE THAT PROPER TECHNIQUE AND USE OF THE RECOMMENDED BACK-STITCH AS DESCRIBED IN THE IFU FOR THESE DEVICES WAS NOT UTILIZED WHEN CLOSING THE INCISION DURING THE PROCEDURE. ADDITIONAL ITEM REPORTED BY THIS CUSTOMER: 0 MONODERM, MODEL/CATALOG NUMBER: YA-1029Q, LOT NUMBER: MZ02660, EXPIRATION DATE: 07/01/2017, DEVICE MANUFACTURE DATE: 07/19/2012, 510(K) NUMBER: K072028. ANGIOTECH REFERENCES: COMPLAINT NUMBER (B)(4), ITEM NUMBER: VLM-1001-2, YA-1029Q LOT NUMBER: MS01540, MZ02660, MATERIAL: SIZE 2-0 MONODERM, SIZE 0 MONODERM.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH PARTIAL DEHISCENCE OF AN INCISION FOLLOWING A TOTAL KNEE ARTHROPLASTY PROCEDURE. THE DEHISCENCE INCLUDED ALL THREE (3) LAYERS OF TISSUE LOCATED AT THE PROXIMAL END OF THE INCISION. THE INCISION REQUIRED WASHOUT AND WAS RE-SUTURED WITHOUT FURTHER INCIDENT. THE SURGEON AND PA WERE TRAINED AND HAVE ONLY BEGUN UTILIZING THE QUILL DEVICES SINCE JUNE 2013. THE SURGEON STATED THAT THE PREOPERATIVE STATE OF THE TISSUE WAS IN GOOD CONDITION AND THERE WERE NO REPORTS OF ANY POST-OPERATIVE EVENTS THAT WOULD HAVE AFFECTED THE STRENGTH OR NATURAL HEALING PROCESS OF THE INCISION. THE SURGEON ALSO INCLUDED THAT IT'S POSSIBLE THAT THE DEVICE WAS NOT ANCHORED IN THE BEST POSITION UPON COMPLETING CLOSURE OF THE INCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578810 QUILL SRS BARBED SUTURE/NEEDLES NEW SURGICAL SPECIALTIES CORP. VLM-1001-2 MS01540

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention