BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANKLE LOCKING NAIL 10 X 180MM

    MDR report key: 9166782 · Received October 8, 2019

    Report

    Report Number
    0001825034-2019-04549
    Event Type
    Malfunction
    Date Received
    October 8, 2019
    Report Date
    October 22, 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). REPORTED EVENT WAS CONSIDERED CONFIRMED AS THE RADIOGRAPHS SHOW A 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 27914, LAG SCREW GUIDE WIRE 3.2X460MM, 980630. 27914, LAG SCREW GUIDE WIRE 3.2X460MM, 765620. 27984, 4.3MM CROWE POINT TWIST DRILL, 809470. 41010, CALIBRATED DRILL 4.3MM, 809760. 14-440115, ANKLE LOCKING NAIL 10 X 150MM, 980500. 14-440118, ANKLE LOCKING NAIL 10 X 180MM, 518700. 14-405046, TI-DBLE LEAD CORT 5.0X46MM SCR, 729640. 14-405065, TI-DBLE LEAD CORT 5.0X65MM SCR, 670000. 14-405028, TI-DBLE LEAD CORT 5.0X28MM SCR, 374520. 14-405050, TI-DBLE LEAD CORT 5.0X50MM SCR, 783290. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-02314 AND 0001825034-2019-04548.

    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
    963177 ANKLE LOCKING NAIL 10 X 180MM PROSTHESIS TRAUMA HSB ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1