BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWNFX TI 2.8 HS STR ANCHR 2 DRBRD NDL

    MDR report key: 2884720 · Received December 25, 2012

    Report

    Report Number
    1219602-2012-00361
    Event Type
    Malfunction
    Date Received
    December 25, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 30, 2012
    Manufacturer
    SMITH & NEPHEW MANSFIELD MANUFACTURING SITE
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ONE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS RETURNED WITH THE DISTAL END OF THE INSERTER SECTIONED/CUT. THIS WAS DONE FOR ANALYSIS BY THE REPORTER. EXAMINATION OF THE SECTIONED PIECE SHOWED THE ANCHOR EYELET REMAINS IN THE INSERTER SHAFT, THE HEX OF THE ANCHOR IS NO LONGER ALIGNED WITH THE INSERTER HEX. THIS CONDITION IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED DURING INSERTION. IN ADDITION, THE ANALYSIS REPORT PROVIDED FROM SMITH+NEPHEW (B)(4) ALSO INDICATED THE FAILURE TO BE A DUCTILE FRACTURE CAUSED BY EXCESSIVE FORCE APPLIED DURING IMPLANTATION. A REVIEW OF THE DEVICE HISTORY RECORDS AND QUALITY RECORDS ASSOCIATED WITH THE MANUFACTURED LOTS IN QUESTION CONFIRMED THAT NO ADDITIONAL COMPLAINTS HAVE BEEN FILED AND THAT NO ABNORMALITIES WERE REPORTED WITH THIS PRODUCT DURING MANUFACTURE. NO ROOT CAUSE RELATED TO THE MANUFACTURE OF THE DEVICE CAN BE ESTABLISHED. (B)(4).

    Description of Event or Problem · 1

    DURING INSERTION INTO THE TALUS, THE ANCHOR BROKE INTO TWO PIECES, THE EYELET AND THE SCREW. THE PROCEDURE WAS COMPLETED WITH A BACK-UP DEVICE. THE SCREW REMAINS IN THE BONE OF THE PATIENT. THE SITE WAS PREPPED WITH THE DRILL FOR THE 2.8 MM SUTURE ANCHOR AND AO TECHNIQUE WAS UTILIZED. THE DOCTOR IS AN EXPERIENCED SURGEON AND USES MORE THAN 50 DEVICES PER YEAR. ACCORDING TO THE DOCTOR, HE DIDN'T INSERT THE ANCHOR FORCEDLY. SPECIFIC LOT USED UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TWNFX TI 2.8 HS STR ANCHR 2 DRBRD NDL TWNFX TI 2.8 HS STR ANCHR 2 DRBRD NDL MBI SMITH & NEPHEW MANSFIELD MANUFACTURING SITE 7210301

    Patients

    Seq Age Sex Outcome Treatment
    1