BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    MDR report key: 13481010 · Received February 8, 2022

    Report

    Report Number
    1219602-2022-00180
    Event Type
    Injury
    Date Received
    February 8, 2022
    Date of Event
    January 19, 2022
    Report Date
    June 19, 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
    CO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: CASE- (B)(4). 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. 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 OF THE PART DETERMINED THIS WAS A REPEAT EVENT. 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. THE IFU, FAST FIX 360 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. THERE WAS NO WAY TO DETERMINE IF THE DEVICE CONTRIBUTED TO THE REPORTED EVENT. THE COMPLAINT WAS NOT CONFIRMED. 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.

    Additional Manufacturer Narrative · 0

    H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION FOUND THAT THE SUTURE AND BOTH ANCHORS WERE RETURNED DETACHED FROM THE DEVICE. THE DEPTH LIMITER BUTTON WAS NOT IN THE DEFAULT POSITION. THE ACTUATOR TIP WAS IN THE T1 POSITION. A FUNCTIONAL EVALUATION REVEALED THAT THE ACTUATOR TIP FUNCTIONED AS DESIGNED. 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 OF THE PART DETERMINED THIS WAS A REPEAT EVENT. 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. THE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE REPORTED MALFUNCTION COULD NOT BE DUPLICATED DURING THE PRODUCT EVALUATION PROCESS. FACTOR THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE INADVERTENTLY BENDING OF THE NEEDLE/OVERMOLD ASSEMBLY. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE IN AN ARTHROSCOPY, THREE FAST-FIX HAD PROBLEMS (PN: 72202468, LOT NUMBERS: 2070814, 2075937 & 2080948), THE T1 CAME OUT VERY WELL, AT THE MOMENT OF TRY TO USE THE T2 , THIS ONE DID NOT COME OUT, THEY TRIED SEVERAL TIMES LOWERING THE GRAY PART IN ITS ENTIRETY AND THE SECOND PEEK NEVER WENT DOWN, SO IT WAS NECESSARY TO REMOVE THIS SUTURE FROM THE PATIENT, TWO OTHER SUTURES FROM DIFFERENT BATCHES WERE PASSED, WHICH FAILED IN THE SAME WAY. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY AND WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904007 FAST-FIX 360 CURVED NDL DELIVERY SYS SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 72202468 2080948 00885554023077

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Other