BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA FAST-FIX AB ASSEMBLY - CURVED

    MDR report key: 11952957 · Received June 7, 2021

    Report

    Report Number
    1219602-2021-01304
    Event Type
    Injury
    Date Received
    June 7, 2021
    Date of Event
    May 19, 2021
    Report Date
    December 1, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    UDI-DI
    03596010597229
    PMA / PMN Number
    K151105
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE, USED IN TREATMENT, WAS RECEIVED FOR EVALUATION. THERE WAS A RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION OR WOULD NOT BE ABLE TO PERFORM AS INTENDED. 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 REVIEW OF RISK MANAGEMENT FILES FOUND THAT THE REPORTED FAILURE WAS DOCUMENTED APPROPRIATELY. A VISUAL INSPECTION REVEALED THE DEVICE WAS OUTSIDE OF ORIGINAL PACKAGING. THE DEVICE WAS IN THE FULLY ACTUATED POSITION. THE ANCHORS AND SUTURE WERE RETURNED DETACHED FROM THE NEEDLE. THE DEPTH TUBE WAS NOT RETURNED WITH THE DEVICE. NO PHYSICAL DAMAGE VISIBLE. A FUNCTIONAL EVALUATION REVEALED THE DEVICE ACTUATOR AND DEPLOYMENT NEEDLE FUNCTION AS INTENDED. THE COMPLAINT WAS CONFIRMED. FACTORS, WHICH COULD HAVE CONTRIBUTED TO THE COMPLAINT EVENT, INCLUDE AN APPLICATION OF UNINTENDED INAPPROPRIATE OR EXCESSIVE FORCE TO PREMATURELY ACTIVATE THE DEVICE. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE, USED IN TREATMENT, WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION OR WOULD NOT BE ABLE TO PERFORM AS INTENDED. 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 REVIEW OF RISK MANAGEMENT FILES FOUND THAT THE REPORTED FAILURE WAS DOCUMENTED APPROPRIATELY. A RELATIONSHIP, IF ANY, BETWEEN THE SUBJECT DEVICE AND THE REPORTED EVENT COULD NOT BE DETERMINED. 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 · 1

    INTERNAL COMPLAINT REFERENCE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE, THE ULTRA FAST-FIX DEPLOYED THE T BARS TOGETHER. ALL TS WERE REMOVED. IT IS UNKNOWN HOW WERE THEY REMOVED. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. NO DELAY AND NO OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844648 ULTRA FAST-FIX AB ASSEMBLY - CURVED SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 72201494 2068039 03596010597229

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O