BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANKLE LOCKING NAIL 10 X 150MM

    MDR report key: 8647854 · Received May 28, 2019

    Report

    Report Number
    0001825034-2019-02314
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (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 , 14-440118 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 , 14-410002 BEAD TIP GD WIRE 2.6MM X 80CM 337180 . 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: 0001825034-2019-04548 AND 0001825034-2019-04549.

    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.

    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. ATTEMPTS WERE MADE TO GAIN MORE INFORMATION HOWEVER, NO INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438057 ANKLE LOCKING NAIL 10 X 150MM PROSTHESIS, TRAUMA HSB ZIMMER BIOMET, INC. N/A 980500

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O