BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA FAST-FIX AB ASSEMBLY - CURVED

    MDR report key: 10151836 · Received June 15, 2020

    Report

    Report Number
    1219602-2020-00924
    Event Type
    Injury
    Date Received
    June 15, 2020
    Date of Event
    June 2, 2020
    Report Date
    July 9, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    PMA / PMN Number
    K151105
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ¿H10 H3, H6: THE REPORTED 72201494 CURVED ULTRA FAST-FIX AB ASSEMBLY USED IN TREATMENT, HAS BEEN RETURNED FOR EVALUATION. THE INFORMATION PROVIDED STATES: ¿DURING A MENISCUS REPAIR SURGERY, TWO "ULTRA FAST FIX AB" DEVICES HAVE FAILED. THE FIRST "ULTRA FAST FIX AB" DEVICE (LOT: 2030871) COULD NOT DEPLOY THE T1 IMPLANT. THE SECOND "ULTRA FAST FIX AB" DEVICE (LOT: 2025379) COULD NOT DEPLOY THE T2 IMPLANT." DEVICE (LOT: 2030871) COULD NOT DEPLOY THE T1 IMPLANT¿. VISUAL ASSESSMENT SHOWED DEVICE WAS BENT. T1 AND T2 REMAINED ON DELIVERY NEEDLE. DEPTH LIMITER WAS CUT TO SURGEON¿S DESIRED LENGTH. AN EXACT ROOT CAUSE CANNOT BE DETERMINED WITH CONFIDENCE. PER THE DEVICE IFU (10600327) UNDER WARNINGS IT STATES ¿DO NOT BEND DELIVERY NEEDLE¿. THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A REVIEW OF THE COMPLAINT AND MANUFACTURING RECORDS WAS PERFORMED AND INDICATED SIMILAR ALLEGATIONS FOR THE LOT NUMBER REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A MENISCUS REPAIR SURGERY, TWO "ULTRA FAST FIX AB" DEVICES HAVE FAILED. THE FIRST "ULTRA FAST FIX AB" DEVICE (LOT: 2030871) COULD NOT DEPLOY THE T1 IMPLANT. THE SECOND "ULTRA FAST FIX AB" DEVICE (LOT: 2025379) COULD NOT DEPLOY THE T2 IMPLANT. IT IS UNKNOWN IF A BACK-UP DEVICE WAS AVAILABLE OR IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616657 ULTRA FAST-FIX AB ASSEMBLY - CURVED SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 2025379

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention