BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA FASTFIX AB CURVED NEEDLE DELIVERY SYSTEM W/SPLIT CANNULA

    MDR report key: 2485730 · Received March 9, 2012

    Report

    Report Number
    1219602-2012-00048
    Event Type
    Malfunction
    Date Received
    March 9, 2012
    Date of Event
    February 2, 2012
    Report Date
    February 15, 2012
    Manufacturer
    SMITH & NEPHEW MANSFIELD MANUFACTURING SITE
    Product Code
    GAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW, INC. ENDOSCOPY DIVISION IS SUBMITTING THE ENCLOSED REPORT TO COMPLY WITH 21 CFR 803, THE MDR REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY SMITH & NEPHEW INC. ENDOSCOPY WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE OF THE REPORT WAS REQUIRED BY FDA. (B)(4).

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE DEVICE IT WAS CONFIRMED THAT BOTH T1 AND T2 REMAIN ON THE INSERTION NEEDLE. THEREFORE THE INCIDENT BECOME NOT REPORTABLE. THIS FOLLOW UP REPORT IS BEING SUBMITTED TO CORRECT THE INFORMATION ON THE INITIAL REPORT WHICH STATE T1 WAS LEFT IN THE PATIENT. THE RETURNED DEVICE WAS EVALUATED AND IT WAS EVIDENT THAT T1 BACKED UP AND GOT STUCK ON THE DIMPLE. THE DIMPLE HEIGHT AND BELLY DIAMETER OF THE IMPLANT WERE MEASURED AND FOUND TO BE WITHIN SPECIFICATION. NO ROOT CAUSE RELATED TO THE MANUFACTURE OF THE DEVICE CAN BE DETERMINED. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    T2 DID NOT DEPLOY AND T1 WAS LEFT IN THE PATIENT DURING A KNEE REPAIR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA FASTFIX AB CURVED NEEDLE DELIVERY SYSTEM W/SPLIT CANNULA ULTRA FAST-FIX AB ASSEMBLY - CURVED GAT SMITH & NEPHEW MANSFIELD MANUFACTURING SITE 72201494 50386582

    Patients

    Seq Age Sex Outcome Treatment
    1