BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWINFIX TI 5.0 ULTRABRAID

    MDR report key: 1350227 · Received January 15, 2009

    Report

    Report Number
    1219602-2009-00008
    Event Type
    Malfunction
    Date Received
    January 15, 2009
    Date of Event
    October 27, 2008
    Report Date
    December 17, 2008
    Manufacturer
    SMITH & NEPHEW INC. ENDOSCOPY DIVISION
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED FOR EVALUATION. DEVICE WAS RECEIVED WITH THE ANCHOR BROKEN FREE AT THE EYELET LOCATION. THE HEXED PORTION REMAINS INTACT WITH THE SHAFT AND SUTURE REMAINS INTACT WITH INSERTER. THERE ARE NO VOIDS IN THE MATERIAL AT THE BREAK LOCATION. THEREFORE, NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE ANCHOR BROKE BELOW THE EYLET CLOSER TO THE THREADS. CORTICAL BONE OF THE HUMERAL HEAD WAS SHAVED WITH ABRADER AND THE SITE WAS PREDRILLED. BROKEN THREADS REMAIN IN THE PATIENT. TWO OTHER ANCHORS WERE IMPLANTED SUCCESSFULLY USING THE SAME TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TWINFIX TI 5.0 ULTRABRAID TWINFIX TI 5.0 MBI SMITH & NEPHEW INC. ENDOSCOPY DIVISION 72200755 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1