BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANKLE LOCKING NAIL 10 X 180MM

    MDR report key: 6256634 · Received January 17, 2017

    Report

    Report Number
    0001825034-2017-00198
    Event Type
    Injury
    Date Received
    January 17, 2017
    Date of Event
    April 17, 2017
    Report Date
    September 14, 2017
    Manufacturer
    BIOMET TRAUMA
    Product Code
    HSB
    PMA / PMN Number
    PK091976
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT COULD NOT BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE DEVICE WAS NOT RETURNED FOR EVALUATION. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    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 THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. UNIQUE IDENTIFIER - UDI # - (B)(4). CONCOMITANT MEDICAL PRODUCT(S) ¿ CORTICAL SCREW 5X26MM, CATALOG#: 14-405026 LOT#: 211330; CORTICAL SCREW 5X26MM, CATALOG#: 14-405026 LOT#: 574080; CORTICAL SCREW 5X70MM, CATALOG#: 14-405070 LOT#: 069190. THERAPY DATE - UNKNOWN FUTURE DATE IN 2017.

    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. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    PATIENT HAS BEEN INDICATED FOR A REVISION PROCEDURE OF AN ANKLE NAIL TO A PATIENT MATCHED ANKLE NAIL FOR UNKNOWN REASONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE OF AN ANKLE NAIL DUE TO THE NAIL FRACTURING APPROXIMATELY 18 MONTHS POST-IMPLANTATION. THE NAIL WAS REMOVED AND REPLACED WITH A CUSTOM NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39610 ANKLE LOCKING NAIL 10 X 180MM ROD, FIXATION HSB BIOMET TRAUMA N/A 492810

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R