BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 110MM-STERILE

    MDR report key: 2852070 · Received November 30, 2012

    Report

    Report Number
    3003506883-2012-00377
    Event Type
    Injury
    Date Received
    November 30, 2012
    Report Date
    November 3, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. 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.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH TFN NAIL, HELICAL BLADE AND LOCKING SCREW ON (B)(6) 2011. PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2012, FOR REMOVAL OF HARDWARE. IT WAS REPORTED THAT THERE WAS A MEDIAL MIGRATION OF THE HELICAL BLADE DUE TO AVASCULAR NECROSIS. PATIENT WAS REVISED TO A TOTAL HIP REPLACEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THIS IS 2 OF 3 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 11.0MM TI HELICAL BLADE 110MM-STERILE HELICAL BLADE HSB SYNTHES ELMIRA 6648420

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention NAIL, LOCKING SCREW