BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIV-FEMNAIL Ø13 L360 SST

    MDR report key: 3171602 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-03100
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Date of Event
    October 17, 2011
    Report Date
    November 22, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. NAIL IS PARTIALLY BROKEN AT THE STATIC PROXIMAL LOCKING HOLE. THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATES AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD ISO 5832-1. THE FRACTURE FACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY. THERE IS EVIDENCE THAT THE MATERIAL NEXT TO THE LOCKING WAS WEAKENED BY THE CONTINUOUS LOADS OVER THE YEARS AND THAT FINALLY FATIGUE OF THE MATERIAL CAUSED THIS BREAKAGE. SYNTHES IS NOT AWARE OF ANY SIMILAR COMPLAINT REGARDING THIS ARTICLE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: A UNIVERSAL FEMORAL NAIL WAS IMPLANTED IN 2003. THE FRACTURE HEALED. DURING THE PLANNED REMOVAL PROCEDURE ON (B)(6) 2011, THE UNIVERSAL FEMORAL NAIL WAS PARTIALLY BROKEN AT THE STATIC PROXIMAL LOCKING HOLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272611 UNIV-FEMNAIL Ø13 L360 SST HSB SYNTHES GMBH 2123

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR