BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPERT A2FN Ø12 R CANN L300 TAN LIGHT GR

    MDR report key: 3161294 · Received June 11, 2013

    Report

    Report Number
    2520274-2013-03153
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 14, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT PRESENTED WITH FEMORAL DIAPHYSEAL FRACTURE. AFTER THE NAIL WAS IMPLANTED, REPORTEDLY THE BALL TIPPED GUIDE WIRE COULD NOT BE REMOVED. THE SURGEON EXTRACTED THE NAIL WITH THE REMAINING GUIDE WIRE. THE SURGEON FOUND A CORTICAL BONE PENETRATED INTO THE HOLLOW PART OF NAIL. THE SURGEON REMOVED THE BONE AND RE-INSERTED THE NAIL. REPORTEDLY WHEN THE NAIL REACHED TO THE DISTAL BONE, THE NAIL WENT THROUGH THE BONE. THE ANTEROPOSTERIOR VIEW SHOWED A SECONDARY FRACTURE. THE ANTERIOR CORTICAL BONE WAS GROUND AND THE INSIDE OR UPPER PART WAS BROKEN. IT WAS REPORTED THE SURGEON INSERTED THE NAIL, THE PROXIMAL PART WAS ROTATED ANTERIORLY AND HE FELT SOME LOAD; THE SURGEON HAMMERED AND SUBSEQUENTLY THE BONE BROKE. THIS IS 1 OF 1 REPORT FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263146 EXPERT A2FN Ø12 R CANN L300 TAN LIGHT GR HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR