BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING SCREW 32MM- FOR IM NAILS-STERILE

    MDR report key: 3160128 · Received June 10, 2013

    Report

    Report Number
    2520274-2013-03282
    Event Type
    Injury
    Date Received
    June 10, 2013
    Report Date
    May 17, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K000089
    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. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. (B)(6).

    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 OPERATING ROOM 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 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260172 5.0MM TI LOCKING SCREW 32MM- FOR IM NAILS-STERILE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention