BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA Ø9 SM 125° L200 TAN

    MDR report key: 3142097 · Received June 3, 2013

    Report

    Report Number
    8030965-2013-02264
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    January 18, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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). A 510K#: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE PFNA BROKE AT THE DISTAL LOCKING HOLE. THE DIMENSIONS OF THE PFNA WERE INSPECTED AND CORRESPONDED WITH THE TECHNICAL DRAWINGS OF THE MANUFACTURER AND THE SPECIFICATIONS. ALTERNATING STRESSES DURING THE BURDEN OF WEIGHT LED TO THE FATIGUE OF THE MATERIAL AND TO THE IMPLANT BREAKING. THE PFNA COULD NOT WITHSTAND THE IMPACT OF THE LOAD WHICH EVENTUALLY LED TO THE RUPTURING OF THE IMPLANT AS A RESULT OF MATERIAL OVERLOAD AND FATIGUE. THERE WAS NO SIGN OF MATERIAL OR MANUFACTURING DEFECTS COULD BE DETECTED IN THE PFNA INSPECTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT BREAKAGE WAS DUE TO PROLONGED OR DELAYED HEALING OF THE BREAK. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244380 PFNA Ø9 SM 125° L200 TAN JDW SYNTHES GMBH 2654355

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention