BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPERT A2FN Ø11 R CANN L360 TAN LIGHT GR

    MDR report key: 3132183 · Received May 29, 2013

    Report

    Report Number
    8030965-2013-02442
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 30, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE END-CAP MOUNTED ON TOP OF THE NAIL WAS RECEIVED AND EVALUATED. THE CAP COULD BE REMOVED FROM THE NAIL WITH INCREASED FORCE. DRIED RESIDUES OF BLOOD BETWEEN THE CAP AND NAIL WERE DISCOVERED. THE COMPLAINT CONDITION IS LIKELY THE RESULT OF THE BLOOD. THE NAIL WAS MANUFACTURED IN 2011, 12 PIECES ACCORDING TO OUR SPECIFICATIONS. NO PRODUCT FAULT FOR BOTH ARTICLES COULD BE DETECTED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(6) INDICATED A SURGEON IN (B)(6) REPORTED: THE SURGEON INSERTED AN A2FN NAIL SCREW AND ENDCAP ON (B)(6) 2012. ON (B)(6) 2013 SURGEON TRIED TO EXTRACT THE NAIL AFTER HE CONFIRMED THE BONE HEALING. THE SURGEON EXTRACTED THE DISTAL SCREW SMOOTHLY; HOWEVER THE END CAP COULD NOT BE ROTATED ABSOLUTELY AND SURGEON COULD NOT REMOVE AGAIN AFTER THE GRINDING OF THE SURROUND BONE. FINALLY THE SURGEON CLOSED THE SURGICAL INCISION WITHOUT EXTRACTING THE NAIL. ON (B)(6), THE OPERATION WAS PERFORMED. THE DOCTOR REMOVED THE NAIL BY USING A HOOK FOR NAIL REMOVING PROCEDURE AND SOFT-WIRE AND CLAMP WHICH WAS PREPARED AT HOSPITAL. THIS IS 1 OF 2 REPORTS FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235801 EXPERT A2FN Ø11 R CANN L360 TAN LIGHT GR HSB SYNTHES GMBH 7594491

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention