BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANKLE LOCKING NAIL 10 X 150MM

    MDR report key: 8647877 · Received May 28, 2019

    Report

    Report Number
    0001825034-2019-02318
    Event Type
    Malfunction
    Date Received
    May 28, 2019
    Report Date
    October 22, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSB
    PMA / PMN Number
    K081243
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    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 THAT THERE IS A VERY SUBTLE FRACTURE OF THE FIXATION NAIL. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 14-405032 TI-DBLE LEAD CORT 5.0X32MM SCR 046630,  14-405036 TI-DBLE LEAD CORT 5.0X36MM SCR 331100, 14-405048 TI-DBLE LEAD CORT 5.0X48MM SCR 517320,  14-405052 TI-DBLE LEAD CORT 5.0X52MM SCR 756530,  14-405075 TI-DBLE LEAD CORT 5.0X75MM SCR 416520,  14-440041 7MM X 200MM CANNULATED DRILL 294490,  14-440115 ANKLE LOCKING NAIL 10 X 150MM 639680,  950095  3.2MM STEINMANN PIN STERILE 871000,   14-410002 BEAD TIP GD WIRE 2.6MM X 80CM 059220.  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. POST OPERATIVE X RAYS NOTES BONE QUALITY IS OSTEOPENIC, AND CONFIRMS FRACTURE OF NAIL. ATTEMPTS WERE MADE TO GAIN MORE INFORMATION HOWEVER, NO INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438056 ANKLE LOCKING NAIL 10 X 150MM PROSTHESIS, TRAUMA HSB ZIMMER BIOMET, INC. N/A 639680

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O