BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 15247259 · Received August 18, 2022

    Report

    Report Number
    1219602-2022-01183
    Event Type
    Injury
    Date Received
    August 18, 2022
    Date of Event
    July 25, 2022
    Report Date
    July 30, 2023
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    UDI-DI
    00885554023077
    PMA / PMN Number
    K092508
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    H10: D4, LOT NO.: THE FOLLOWING ARE THE LOT NUMBERS REPORTED: 2080933, 2080934 AND 2080935. HOWEVER, IT IS UNKNOWN WHICH OF THE THREE FAILED ON THE REPORTED EVENT. D4, EXP. DATE: EXPIRATION DATES FOR THE TWO LOTS REPORTED: 12-OCT-2024 (LOT 2080933 ), 12-OCT-2024 (LOT 2080934) AND 12-OCT-2024 (LOT 2080935). H4, MGF. DATE: MANUFACTURING DATES FOR TWO LOTS REPORTED: 12-OCT-2021 (LOT 2080933 ), 12-OCT-2021 (LOT 2080934) AND 12-OCT-2021 (LOT 2080935). 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. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A MANUFACTURING RECORD REVIEW COULD NOT BE CONDUCTED. BASED ON THE INFORMATION AVAILABLE, 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. AN EVALUATION OF THE CUSTOMER PROVIDED IMAGES SHOWED IN IMAGE 1 THE DEVICE INSIDE A SHIPPING POUCH. T1/T2/SUTURE ARE OFF THE NEEDLE AND LAYING BESIDE THE DEVICE. THE NEEDLE IS BENT. IMAGE 2 SHOWS TWO BOX END LABELS WITH THE BATCH NUMBERS OF 2080933 AND 2080935. IMAGE 3 SHOWS THE HANDLE END IN A SHIPPING POUCH. T1/T2/SUTURE ARE LAYING BESIDE THE DEVICE. IMAGE 4 SHOWS THE BOX END LABEL WITH THE BATCH NUMBER OF 2080934. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON PROPER USE OF THE DEVICE AND POTENTIAL TROUBLESHOOTING METHODS TO PREVENT FUTURE REOCCURRENCE OF THE REPORTED EVENT. 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. H11: H2: CORRECTION ON D8 AND H6 (HEALTH EFFECT - IMPACT CODE).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MENISCUS REPAIR CASE, A FAST FIX'S T2 DEPLOYED SIMULTANEOUSLY WITH THE T1. BOTH IMPLANTS WERE REMOVED WITH A GRASPER BY THE SURGEON. SURGERY WAS RESUMED WITHOUT ANY DELAY WITH A BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2370851 FAST-FIX 360 CURVED NDL DELIVERY SYS SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 72202468 UNKNOWN 00885554023077

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention