BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 100MM-STERILE

    MDR report key: 3150322 · Received June 6, 2013

    Report

    Report Number
    3003506883-2013-00249
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 11, 2013
    Report Date
    May 10, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 11MM TI HELICAL BLADES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO ANOMALIES NOTED.

    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 RECORDS HAS BEEN REQUESTED. PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH TROCHANTERIC FIXATION NAIL CONSTRUCT ON AN UNSPECIFIED DATE. REPORTEDLY THE PATIENT FELL AND CONSEQUENTLY THE PATIENT SUSTAINED A NEW FRACTURE NEAR THE KNEE. PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2013 FOR REVISION SURGERY. THE SURGEON REMOVED ALL HARDWARE. THE PATIENT WAS REVISED WITH A LATERAL ENTRY LONG RECON NAIL TO COVER THE OLD INJURY AND REPAIR THE NEW FRACTURE. REPORTEDLY ALL HARDWARE WAS INTACT. THIS IS 2 OF 3 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251325 11.0MM TI HELICAL BLADE 100MM-STERILE HSB SYNTHES ELMIRA 7026901

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention