BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARBON TARGET ARM - ANKLE NAIL

    MDR report key: 7288712 · Received February 22, 2018

    Report

    Report Number
    0001825034-2018-01264
    Event Type
    Malfunction
    Date Received
    February 22, 2018
    Date of Event
    January 26, 2018
    Report Date
    May 24, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CORRECTED LOT NUMBER. 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 · 1

    (B)(4). MULTIPLE MDR'S WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORT(S): 0001825034 - 2018 - 01263. CONCOMITANT MEDICAL PRODUCTS: 14-440115 ANKLE LOCKING NAIL 10 X 150MM, LOT 884280, 14-440118 ANKLE LOCKING NAIL 10 X 180MM 838290 , 14-405048 TI-DBLE LEAD CORT 5.0X48MM SCR 088200 , 14-405032 TI-DBLE LEAD CORT 5.0X32MM SCR 857400, 14-405022 TI-DBLE LEAD CORT 5.0X22MM SCR 417610, 14-405020 TI-DBLE LEAD CORT 5.0X20MM SCR 566550 , 14-440052 3.2X320MM K-WIRE WITH TROCAR 279440, 14-440041 7MM X 200MM CANNULATED DRILL 478620, 14-410002 BEAD TIP GD WIRE 2.6MM X 80CM 279300, 41010 CALIBRATED DRILL 4.3MMX320MM 091220. 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. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. VISUAL ANALYSIS OF THE RETURNED JIG. THERE IS NO DAMAGE TO ANY OF THE TARGETING HOLES IN THE JIG. DIMENSIONAL ANALYSIS CONFIRMED THE POSITION OF ALL THREE PROXIMAL HOLES TO BE IN CONFORMANCE WITH SPECIFICATIONS. DHR WAS REVIEWED AND NO DISCREPANCIES 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 · 1

    IT WAS REPORTED THE NAIL TARGETER MISSED ON THE TWO PROXIMAL SCREWS RESULTING IN HAVING TO USE A LONGER NAIL DEVICE AFTER A 20 MINUTE DELAY TO SURGERY. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133240 CARBON TARGET ARM - ANKLE NAIL ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ZIMMER BIOMET, INC. N/A 056130

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention