BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA-II BLADE L100 TAN

    MDR report key: 2851950 · Received November 29, 2012

    Report

    Report Number
    2520274-2012-03470
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    July 22, 2009
    Report Date
    July 30, 2009
    Manufacturer
    SYNTHES
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE WAS USED FOR TREATMENT. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED (B)(4) 2011. A REVIEW OF THE EVENTS ASSOCIATED WITH THE REQUEST WAS PERFORMED AND IT WAS DETERMINED THAT NONE OF THE EVENTS CONSTITUTES SYSTEMIC ISSUES RELATED TO PRODUCT QUALITY, CHANGES IN PRODUCT DESIGN, METHOD OF USE, OR CHANGES IN EXPECTED RISK THRESHOLDS. REVIEW OF THE DATA ALSO INDICATED NO SIGNIFICANT CHANGE IN RISK/BENEFIT OF EACH PRODUCT CATEGORY, NO EVIDENCE OF DEFICIENCIES IN THE DESIGN, LABELING, OR MANUFACTURE OF THE DEVICE. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    (B)(6) COMPLAINT HANDLING UNIT REPORTED A BLADE PENETRATED THE FEMORAL HEAD. THE PATIENT HAS DEMENTIA SO SHE COULD NOT CONTROL THE ACTIVITY DURING REHABILITATION. ON (B)(6) 2009, THE SURGEON MADE THE SURGICAL OPERATION USING A (B)(4) PROXIMAL FEMORAL NAIL ANTIROTATION SYSTEM. ON (B)(6) 2009, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2009, THE SURGEON FOUND THE PENETRATED (B)(4) BLADE BY X-RAY. ON (B)(6) 2009, ONLY THE BLADE WAS RETRIEVED NAIL AND LOCKING BOLT WERE LEFT IN THE FEMORAL BONE. THE SURGEON DECIDED THAT THE TROCHANTERIC FRACTURE WAS ALMOST HEALED, SO HE INSERTED THE BONE GRAFT INTO THE HOLE ON THE FEMORAL HEAD AND CLOSED THE WOUND. THE PATIENT IS UNDER THE GOOD CONDITION NOW.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention