BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FAST-FIX 360 REVERSED CURVE NDL DELIV

    MDR report key: 19268537 · Received May 8, 2024

    Report

    Report Number
    1219602-2024-00969
    Event Type
    Injury
    Date Received
    May 8, 2024
    Date of Event
    August 1, 2023
    Report Date
    June 13, 2024
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    UDI-DI
    00885554023084
    PMA / PMN Number
    K121861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE (B)(4).

    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 WERE 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. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNKNOWN NUMBER OF MENISCUS REPAIR PROCEDURES, SEVERAL FAST-FIX DEVICES HAD THE FOLLOWING MALFUNCTION FAILURES: FALLING ANCHORS FROM THE DELIVERY NEEDLE, OR BREAKING DELIVERY NEEDLE INSIDE THE KNEE JOINT, OR THAT DUE TO LARGE PUNCTURE SITE, THE ANCHORS WOULD FALL OFF OR WERE PULLED OUT EASILY. A TOTAL OF 3 DIFFERENT PART NUMBERS (72202467, 72202468, AND 72202469) FROM 4 DIFFERENT LOT NUMBERS (2111594, 2095270, 2100051, AND 2124201) WERE REPORTED. HOWEVER, IT WAS NOT POSSIBLE TO DETERMINE WHICH LOT NUMBER HAD EACH OF THESE FAILURES. THEREFORE, EACH LOT NUMBER PROVIDED WILL INCLUDE ALL THE PREVIOUS LISTED MALFUNCTIONS. IN ADDITION, AFTER REPEATED ATTEMPTS AT SUTURING, THE MENISCUS WAS DESTROYED TO THE POINT IT HAD TO BE REMOVED. MOST OF THE TIMES, DUE TO THIS UNRECOVERABLE DAMAGE THE OPERATION HAD TO BE COMPLETED VIA MENISCECTOMY AND PLACING COMPETITOR JUGGERSTITCH AND FIBERSTITCH MENISCAL IMPLANTS INSTEAD. AS A RESULT, SIGNIFICANT SURGICAL DELAYS GREATER THAN 30 MINUTES TOOK PLACE, AND NO FURTHER INFORMATION OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773205 FAST-FIX 360 REVERSED CURVE NDL DELIV SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 2124201 00885554023084

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R