BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA-II BLADE L105 TAN

    MDR report key: 2940952 · Received February 4, 2013

    Report

    Report Number
    8030965-2013-00250
    Event Type
    Injury
    Date Received
    February 4, 2013
    Report Date
    June 18, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: PATIENT WAS IMPLANTED WITH PFNA II NAIL, BOLT AND BLADE CONSTRUCT FOR A FEMORAL NECK FRACTURE ON (B)(6) 2012. IN (B)(6) 2012, PATIENT BEGAN HALF-WEIGHT BEARING. IN (B)(6) 2012, PATIENT BEGAN BEARING FULL WEIGHT. ON (B)(6) 2012 THE SURGEON, VIA X-RAY, FOUND THAT THE DISTAL LOCKING BOLT WAS BROKEN. ON (B)(6) 2012, THE SURGEON FOUND THE PFNA II NAIL WAS BROKEN. THE PFNA NAIL BROKE AT THE 130 DEGREE HOLE LEAD-THROUGH FOR THE SPIRAL BLADE ON THE NAILS PROXIMAL PART. THE PATIENT RETURNED TO THE OR ON (B)(6) 2012 FOR HARDWARE REMOVAL. AT THIS TIME, PATIENT WAS REVISED WITH BHA. POST-OPERATIVE FOLLOW UP DID NOT REVEAL ANY FURTHER ISSUES. THIS IS 3 OF 3 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46848 PFNA-II BLADE L105 TAN PFNA BLADE KTT SYNTHES GMBH 2703050

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention