BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANKLE LOCKING NAIL 10 X 150MM

    MDR report key: 8640206 · Received May 24, 2019

    Report

    Report Number
    0001825034-2019-02312
    Event Type
    Malfunction
    Date Received
    May 24, 2019
    Report Date
    October 31, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSB
    PMA / PMN Number
    K081243
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS : CATALOG #: 14-410002, BEAD TIP GD WIRE 2.6MM X 80CM, LOT # 844790, CATALOG #: 27914, LAG SCREW GUIDE WIRE 3.2X460MM, LOT # 179130, CATALOG #: 14-405028, TI-DBLE LEAD CORT 5.0X28MM SCR, LOT # 943560, CATALOG #: 14-405026, TI-DBLE LEAD CORT 5.0X26MM SCR, LOT # 409760, CATALOG #: 14-405038, TI-DBLE LEAD CORT 5.0X38MM SCR, LOT # 756470, CATALOG #: 14-405034, TI-DBLE LEAD CORT 5.0X34MM SCR, LOT # 192800, CATALOG #: 14-405065, TI-DBLE LEAD CORT 5.0X65MM SCR, LOT # 756580. 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 · 0

    (B)(4). REPORTED EVENT WAS CONSIDERED CONFIRMED DUE TO THE X-RAYS SHOWING EVIDENCE OF A NAIL FRACTURE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT SUSTAINED MECHANICAL BREAKAGE OF NAILS IN THE POST OPERATIVE PERIOD. ATTEMPTS WERE MADE TO GAIN MORE INFORMATION HOWEVER, NO INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436207 ANKLE LOCKING NAIL 10 X 150MM PROSTHESIS, TRAUMA HSB ZIMMER BIOMET, INC. N/A 794490 

    Patients

    Seq Age Sex Outcome Treatment
    1