BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA-II BLADE L100 TAN

    MDR report key: 3171643 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-03197
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Date of Event
    January 11, 2012
    Report Date
    March 7, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THE CARRIED OUT FUNCTIONAL TEST COULD NOT IDENTIFY ANY DEVIATION TO THE SPECIFICATIONS. AFTER DISASSEMBLING, ALL PARTS WERE FOUND IN FAULTLESS CONDITION. THE CAUSE IS UNKNOWN. REVIEWING THE MANUFACTURING AND MATERIAL DOCUMENT SHOWS NO DEVIATION TO THE SPECIFICATION.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT WAS TREATED FOR A TROCHANTERIC FEMORAL FRACTURE ON (B)(6) 2012. AFTER INSERTING OF THE BLADE, IT WAS LOCKED. HOWEVER, THE DOCTOR FELT IT WASN'T RIGHT, SO THE IMAGE WAS CHECKED AND IT WAS FOUND TO NOT BE LOCKED. THEREFORE THE BLADE WAS REMOVED AND REPLACED WITH A 95 MM, WHICH IS ONE SIZE SHORTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272521 PFNA-II BLADE L100 TAN HSB SYNTHES GMBH 2789135

    Patients

    Seq Age Sex Outcome Treatment
    1