BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANKLE NAIL JIG NOSE ING

    MDR report key: 13693404 · Received March 8, 2022

    Report

    Report Number
    0001825034-2022-00506
    Event Type
    Injury
    Date Received
    March 8, 2022
    Date of Event
    February 15, 2022
    Report Date
    July 9, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UNKNOWN PHOENIX NAIL.REPORT SOURCE:FOREIGN COUNTRY: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10: CAT#14-440056 PHOENIX COMPRESSION NUT LOT# 001428. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THE ANKLE DRIVER NOSE WAS RETURNED DAMAGE AND A COMPRESSION NUT WAS SEIZED ON IT. BOTH INSTRUMENTS SHOW SIGNS OF DAMAGE AND USE. THE ANKLE DRIVER NOSE HAS THE 3 PRONGS FRACTURED OFF. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE ROOT CAUSE OF THE REPORTED BROKEN/FRACTURED ISSUE IS ATTRIBUTED TO USE ERROR. PER THE PHOENIX ANKLE ARTHRODESIS NAIL SYSTEM SURGICAL TECHNIQUE, THE COMPRESSION NUT AND COMPRESSION HAT ARE ASSEMBLED ON THE TARGETING JIG NOSE/DRIVER BUSHING. THE CONNECTING BOLT IS THEN PASSED THROUGH THE TARGETING JIG NOSE AND THREADED INTO THE DISTAL END OF THE NAIL. THEREFORE, TO REMOVE THE OUTRIGGER ASSEMBLY FROM THE NAIL IMPLANT, THE CONNECTING BOLT WOULD NEED TO BE REMOVED FIRST. IT WAS REPORTED THAT THE SURGEON DID NOT LOOSEN THE CONNECTING BOLT, BUT INSTEAD TURNED THE COMPRESSION NUT TO REMOVE THE ASSEMBLY. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED FOR THE LOCKED/SEIZED ISSUE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED AT THE END OF AN ANKLE ARTHRODESIS WITH A PHOENIX NAIL, A FRACTURE OF AN INSTRUMENT OCCURRED. THERE WAS A CRACKING SOUND WHEN THE CONNECTING SCREW WAS LOOSENED. PRESUMABLY THE SURGEON MADE A MISTAKE WHEN HE WANTED TO DISCONNECT THE LOCKING BOLD. HE DIDN¿T TURN THE LOCKING BOLD, INSTEAD HE TURNED THE HOLDING DEVICE THAT IS BROKEN, BUT THIS COULD NOT BE CONFIRMED. THE OPERATION COULD BE COMPLETED, INCLUDING THE NAIL END CAP. SMALL PARTS OF THE FRACTURED INSTRUMENT WERE LEFT IN THE SLOTS OF THE NAIL, THEREFORE LEFT IN THE PATIENT AS THE PIECES COULD NOT BE REMOVED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1932370 ANKLE NAIL JIG NOSE ING ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ZIMMER BIOMET, INC. N/A 363180

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other