BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 85MM-STERILE

    MDR report key: 3160126 · Received June 10, 2013

    Report

    Report Number
    3003506883-2013-00251
    Event Type
    Injury
    Date Received
    June 10, 2013
    Report Date
    May 17, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A TROCHANTERIC FIXATION NAIL SYSTEM ON (B)(6) 2012, FOR A HIP FRACTURE. PATIENT RETURNED TO THE SURGEON COMPLAINING OF PAIN. IT WAS DETERMINED THAT THE HELICAL BLADE WAS PROMINENT ON THE LATERAL CORTEX, SO THE PATIENT WAS RETURNED TO THE OR ON (B)(6) 2013, FOR REMOVAL OF THE TFN NAIL, HELICAL BLADE AND DISTAL LOCKING SCREW. PATIENT WAS REVISED TO A HEMIARTHROPLASTY HIP. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261073 11.0MM TI HELICAL BLADE 85MM-STERILE HSB SYNTHES ELMIRA 6711650

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention