BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANKLE LOCKING NAIL 10 X 150MM

    MDR report key: 8646486 · Received May 28, 2019

    Report

    Report Number
    0001825034-2019-02319
    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). CONCOMITANT MEDICAL PRODUCTS : 14-405028 TI-DBLE LEAD CORT 5.0X28MM SCR 617060 , 14-405032 TI-DBLE LEAD CORT 5.0X32MM SCR 443870 , 14-405036 TI-DBLE LEAD CORT 5.0X36MM SCR 325200 , 14-405038 TI-DBLE LEAD CORT 5.0X38MM SCR 211600 , 14-405065 TI-DBLE LEAD CORT 5.0X65MM SCR 227870 , 14-440041 7MM X 200MM CANNULATED DRILL 333333 , 41009  11.5MM - ONE STEP REAMER 082370 , 14-410002 BEAD TIP GD WIRE 2.6MM X 80CM 665230,  41010  CALIBRATED DRILL 4.3MM 706320 , 27914  LAG SCREW GUIDE WIRE 3.2X460MM 963940.  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 NOT CONFIRMED AS THE X-RAYS SAW A SLIGHT BEND OF THE HINDFOOT FUSION NAIL AT THE LEVEL OF THE TALUS WITH APEX LATERAL AND POSTERIOR ANGULATION, CONSISTENT WITH HARDWARE FAILURE. THE COMPLAINT REPORTED IS FOR FRACTURE WHICH COULD NOT BE CONFIRMED FROM THE X-RAY REPORT. 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). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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. X-RAYS PROVIDED WERE REVIEWED AND SHOWS RADIOLUCENCY INDICATING LOOSENING AND BEND OF THE HINDFOOT FUSION CONSISTENT WITH HARDWARE FAILURE. ATTEMPTS WERE MADE TO GAIN MORE INFORMATION HOWEVER, NO INFORMATION WAS RECEIVED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439985 ANKLE LOCKING NAIL 10 X 150MM PROSTHESIS, TRAUMA HSB ZIMMER BIOMET, INC. N/A 980530

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O