BEUDAMED
    FDA Adverse Event Injury Summary report: N

    US NANCY NAIL 450 20/10

    MDR report key: 5823119 · Received July 26, 2016

    Report

    Report Number
    0001825034-2016-02753
    Event Type
    Injury
    Date Received
    July 26, 2016
    Date of Event
    June 8, 2016
    Report Date
    September 7, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HSB
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY. THIS DEVICE IS NOT MANUFACTURED BY ZIMMER BIOMET US; HOWEVER, THIS REPORT IS BEING FILED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE UNDER 510K NUMBER K993956. PRODUCT REQUESTED, NOT YET RETURNED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. (B)(4). EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. VISUAL INSPECTION CONFIRMED REPORTED CONDITION AS THE DISTAL TIP OF THE NAIL IS DEFORMED. THE DEFORMATION MAY HAVE OCCURRED DURING INSERTION INTO THE MEDULLARY CANAL; HOWEVER, A CONCLUSIVE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    DURING A HIP FRACTURE FIXATION PROCEDURE, THE NAIL BECAME DEFORMED. THE NAIL WAS REMOVED AND ANOTHER NAIL WAS AVAILABLE TO COMPLETE THE PROCEDURE WITHOUT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476558 US NANCY NAIL 450 20/10 ROD, FIXATION HSB BIOMET ORTHOPEDICS N/A 5264243

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention