BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA FAST-FIX ASSEMBLY - CURVED EI

    MDR report key: 11112918 · Received January 4, 2021

    Report

    Report Number
    1219602-2021-00015
    Event Type
    Malfunction
    Date Received
    January 4, 2021
    Date of Event
    December 9, 2020
    Report Date
    February 25, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    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. A REVIEW OF THE INSTRUCTIONS FOR USE FOUND: ¿READ THESE INSTRUCTIONS COMPLETELY PRIOR TO USE. DO NOT BEND DELIVERY NEEDLE. DELIVERY INSTRUMENTATION IS REQUIRED FOR PROPER PLACEMENT OF THE IMPLANTS FOR OPTIMAL SURGICAL RESULT. SLIDE THE GOLD TRIGGER FORWARD TO ADVANCE THE SECOND IMPLANT (T2) INTO THE READY POSITION.¿ A REVIEW OF RISK MANAGEMENT FILES FOUND THAT THE REPORTED FAILURE WAS DOCUMENTED APPROPRIATELY. A REVIEW OF THE COMPLAINT REVEALED THERE WERE NO PATIENT INJURIES REPORTED AND NO APPARENT PATIENT IMPACT BASED ON THE DETAILS PROVIDED. THEREFORE, NO FURTHER MEDICAL ASSESSMENT IS WARRANTED. 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 EVALUATION WILL BE REOPENED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT REFERENCE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING AN ARTHROSCOPY USING THE ULTRA FAST-FIX ASSEMBLY - CURVED, T2 DID NOT TRIGGER. THE MALFUNCTION WAS SOLVED WITH A DELAY SHORTER THAN 30 MINUTES WITH NO PATIENT HARM USING A BACK UP DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10240 ULTRA FAST-FIX ASSEMBLY - CURVED EI SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 2053347

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention