BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADV HEALING - TWINFIX

    MDR report key: 2511741 · Received March 30, 2012

    Report

    Report Number
    1219602-2012-00072
    Event Type
    Malfunction
    Date Received
    March 30, 2012
    Date of Event
    January 18, 2012
    Report Date
    March 2, 2012
    Manufacturer
    SMITH & NEPHEW MANSFIELD MANUFACTURING SITE
    Product Code
    MAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW, INC. ENDOSCOPY DIV.; 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 DIV. WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE OF THE REPORT WAS REQUIRED BY FDA. THE DEVICES HAVE NOT BEEN RECEIVED FOR EVALUATION. THE CUSTOMER REPORTED TO SEPARATE LOT NUMBERS WERE USED IN THE PROCEDURE; 50394700 (EXPIRATION 09/30/2016) AND 50384738 (EXPIRATION 06/30/2016); IT IS UNKNOWN WHICH LOT NUMBER WAS INVOLVED IN THE DEVICE FAILURE. (B)(4).

    Description of Event or Problem · 1

    THE SURGEON IS WELL EXPERIENCED AND IN THE SAME SURGERY IMPLANTED 4 UNITS (3 FROM LOT 50394700 AND 1 FROM LOT 50384738). IT IS IMPOSSIBLE TO KNOW WHICH ONE FAILED. PER MALFUNCTION REPORT, DEVICE BROKE IN THE PATIENT AND WAS REMOVED, BUT UNKNOWN HOW. DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADV HEALING - TWINFIX TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL MAI SMITH & NEPHEW MANSFIELD MANUFACTURING SITE 72202602

    Patients

    Seq Age Sex Outcome Treatment
    1