BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANKLE LOCKING NAIL 11 X 150MM

    MDR report key: 8647843 · Received May 28, 2019

    Report

    Report Number
    0001825034-2019-02309
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS : 41010  CALIBRATED DRILL 4.3MM 712610 , 14-410002 BEAD TIP GD WIRE 2.6MM X 80CM 775560 , 14-440041 7MM X 200MM CANNULATED DRILL 555790  , 14-405028 TI-DBLE LEAD CORT 5.0X28MM SCR 264030 , 14-405028 TI-DBLE LEAD CORT 5.0X28MM SCR 412620 , 14-405050 TI-DBLE LEAD CORT 5.0X50MM SCR 523980 , 14-405044 TI-DBLE LEAD CORT 5.0X44MM SCR 208800 , 14-405065 TI-DBLE LEAD CORT 5.0X65MM SCR 756910 . 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 AS THE RADIOGRAPHS SHOW AS SLIGHT DEFORMITY SUGGESTING A NONDISPLACED 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. POST OPERATIVE X RAYS NOTES LATERAL AND POSTERIOR ANGULATION AND DEFORMITY OF THE NAIL COMPONENT. ATTEMPTS WERE MADE TO GAIN MORE INFORMATION HOWEVER, NO INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438051 ANKLE LOCKING NAIL 11 X 150MM PROSTHESIS, TRAUMA HSB ZIMMER BIOMET, INC. N/A 147170

    Patients

    Seq Age Sex Outcome Treatment
    1