BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FF FLEX CRVD INSTR

    MDR report key: 19191502 · Received April 26, 2024

    Report

    Report Number
    1219602-2024-00887
    Event Type
    Injury
    Date Received
    April 26, 2024
    Date of Event
    April 2, 2024
    Report Date
    June 3, 2024
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    UDI-DI
    00885556804704
    PMA / PMN Number
    K203393
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4). THE FOLLOWING ARE THE ADDITIONAL DEVICES USED IN THE SURGERY: 72205324, LOT:2136061; 72205676, LOT: 2139767 AND 72205676, LOT: 2133155.

    Additional Manufacturer Narrative · 0

    H3, H6: A DEVICE DEFICIENCY WAS NOT IDENTIFIED, AND THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATIONS 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. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE, FOUR (4) FAST-FIX FAILED. T1 DID NOT ANCHORED. MENISCUS WAS MANY TIMES PENETRATED, SO IT WAS NOT POSSIBLE TO REPAIR IT. THE PROCEDURE COULD NOT BE COMPLETED, IT WAS CANCELLED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE, FOUR (4) FAST-FIX FAILED. T1 DID NOT ANCHORED. MENISCUS WAS MANY TIMES PENETRATED, SO IT WAS NOT POSSIBLE TO REPAIR IT AND A MENISCUS RESECTION WAS PERFORMED. THE PROCEDURE COULD NOT BE COMPLETED, IT WAS CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871429 FF FLEX CRVD INSTR SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 2139764 00885556804704

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other