BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 17633554 · Received August 28, 2023

    Report

    Report Number
    1219602-2023-01622
    Event Type
    Malfunction
    Date Received
    August 28, 2023
    Date of Event
    August 4, 2023
    Report Date
    October 22, 2023
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    UDI-DI
    00885554023077
    PMA / PMN Number
    K092508
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION REVEALED THE DEVICES WERE RETURNED IN ORIGINAL PACKAGING WITH THE BATCH NUMBER 2111786 OF THE COMPLAINT ON ONE LABEL. A SECOND LABEL WITH BATCH 2117396, WAS PEELED OFF ANOTHER DEVICE BOX AND ADHERED TO THE SAME RETURNED BOX. THE T1, T2, AND SUTURE WERE NOT RETURNED FOR EITHER DEVICE. DEVICE ONE: THE ACTUATOR IS IN THE PRE-T1/POST-T2 POSITION. BIO DEBRIS IS PRESENT. DEVICE TWO: THE NEEDLE ASSEMBLY IS BENT. THE ACTUATOR IS ALMOST TO THE END OF THE NEEDLE AND BIO DEBRIS IS PRESENT. A FUNCTIONAL EVALUATION WAS PERFORMED ON THE RETURNED DEVICE AND FOUND THAT NEITHER DEVICE WILL CYCLE. 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. 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 ROOT CAUSE HAS BEEN ASSOCIATED WITH UNINTENDED USE OF THE DEVICE. FACTORS THAT COULD HAVE CONTRIBUTED TO THE FAILURE INCLUDE INADVERTENTLY BENDING OF THE NEEDLE/OVERMOLD ASSEMBLY. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. LOT NO: 2111786 IS COVERED UNDER (B)(4). REPORT NO: 1219602-2023-01623.** H11: CORRECTED INFORMATION IN A1 (SHOULD BE READ IN BLANK) AND H6 (HEALTH EFFECT - IMPACT CODE).

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MENISCUS REPAIR SURGERY, THE FAST FIX DEVICES FAILED TO DEPLOY THE T2 IMPLANT IN THE KNEE JOINT. BOTH T1 IMPLANTS WERE LEFT IN THE PATIENT, EMBEDDED IN MENISCAL TISSUES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1316594 FAST-FIX 360 CURVED NDL DELIVERY SYS SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 2117396 00885554023077

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown