BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 15247265 · Received August 18, 2022

    Report

    Report Number
    1219602-2022-01185
    Event Type
    Injury
    Date Received
    August 18, 2022
    Date of Event
    July 25, 2022
    Report Date
    September 27, 2022
    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

    H3, H6: THE REPORTED DEVICE WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THERE WAS NO RELATIONSHIP FOUND BETWEEN THE DEVICE AND THE REPORTED EVENT. 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. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED THUS A MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED BUT BASED ON THE INFORMATION AVAILABLE, 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 WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. THERE WAS NO RELATIONSHIP FOUND BETWEEN THE DEVICE AND THE REPORTED EVENT. THE COMPLAINT WAS NOT CONFIRMED. FACTORS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE AN UNINTENDED SECOND ACTUATION OF THE DEVICE OR EXCESSIVE RETRACTION OF THE DEVICE CAUSING T2 TO BE PULLED FROM THE NEEDLE. 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 A MENISCUS REPAIR CASE TWO (2) FAST FIX¿S ((B)(4)) 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MENISCUS REPAIR CASE THE FAST FIX 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
    2370857 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