BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA FAST-FIX ASSEMBLY - CURVED

    MDR report key: 16414749 · Received February 21, 2023

    Report

    Report Number
    1219602-2023-00219
    Event Type
    Injury
    Date Received
    February 21, 2023
    Date of Event
    February 1, 2023
    Report Date
    July 22, 2023
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    UDI-DI
    03596010597205
    PMA / PMN Number
    K072322
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10, H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. THERE WAS A RELATIONSHIP FOUND BETWEEN THE DEVICE AND THE REPORTED EVENT. A VISUAL EVALUATION SHOWED THE NEEDLE ASSEMBLY WAS RETURNED WITH THE BLUE CANNULA WRAPPED AROUND IT. THE T1 AND SUTURE WERE NOT RETURNED. THE T2 IS PAST THE DIMPLE AND CRIMPED INTO THE END OF THE NEEDLE, POSSIBLY BY A SHARP GRASPER. THE NEEDLE AND OVERMOLD ASSEMBLY ARE BENT. THERE APPEARS TO BE A WHITE ADHESIVE AT THE BASE OF THE NEEDLE. THE DEPTH STRAW HAS BEEN TRIMMED. THE ACTUATOR IS DEPLOYED TO THE DIMPLE. A FUNCTIONAL EVALUATION COULD NOT BE PERFORMED DUE TO THE CONDITION THE DEVICE WAS RETURNED IN; THE NEEDLE WAS CRIMPED NOT ALLOWING THE IMPLANT TO BE DEPLOYED. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTED EVENTS. THE INSTRUCTIONS FOR USE WAS REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. THE COMPLAINT WAS CONFIRMED AND THE ROOT CAUSE WAS ASSOCIATED WITH UNINTENDED USE OF THE DEVICE. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE EXCESSIVE FORCE OR TORSION DURING USE OR USE OF SHARP INSTRUMENTS NEAR THE DEVICE TIP. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MENISCUS REPAIR SURGERY, THE T2 IMPLANT OF THE ULTRA FAST-FIX COULD NOT BE DEPLOYED. THE T1 IMPLANT WAS REMOVED USING PLIERS. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1643187 ULTRA FAST-FIX ASSEMBLY - CURVED SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 72201491 2095298 03596010597205

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention