BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANKLE LOCKING NAIL 11 X 180MM X 180MM

    MDR report key: 11606729 · Received April 2, 2021

    Report

    Report Number
    0001825034-2021-00966
    Event Type
    Injury
    Date Received
    April 2, 2021
    Date of Event
    March 18, 2021
    Report Date
    August 9, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSB
    UDI-DI
    00887868093609
    PMA / PMN Number
    K091976
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS AND RADIOGRAPHS RECEIVED. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE NAIL WAS FRACTURED AT THE DYNAMIC LOCKING HOLE THAT OCCURRED DURING THE HEALING PROCESS. THE BROKEN NAIL AND LOCKING PINS WERE REMOVED. A NEW NAIL WAS IMPLANTED WITH NO COMPLICATIONS. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THERE IS A FRACTURE OF THE NAIL WITH ANGULATION APEX DORSAL AT THE LEVEL OF THE TALUS. NO SCREW FRACTURES WERE NOTED. THERE IS RADIOLUCENCY AT THE DISTAL ASPECT OF THE NAIL WITHIN THE CANCELEUS. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THE NAIL WAS FRACTURED INTO 2 PIECES, WITH WEAR OF THE ANODIZED COATING IN SOME LOCATIONS OF THE DEVICE. THE SCREWS HAD THREAD DEFORMATIONS AND THE NAIL HAD CONTACT DAMAGE. THE DEVICE WAS SUBMITTED FOR FURTHER ANALYSIS. ANALYSIS DETERMINED THE FRACTURE IS DUE TO FATIGUE, WHICH THEN LED TO BENDING OVERLOAD. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.THE FOLLOWING SECTIONS WERE UPDATED/CORRECTEDUPDATED: A4; B7.

    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). BIRTH YEAR: (B)(6). CONCOMITANT MEDICAL DEVICES: 14-405024 496870 TI-DBLE LEAD CORT 5.0X24MM SCR; 14-405022 434380 TI-DBLE LEAD CORT 5.0X22MM SCR; 14-405044 752180 TI-DBLE LEAD CORT 5.0X44MM SCR; 14-405026 435030 TI-DBLE LEAD CORT 5.0X26MM SCR; 14-405044 873540 TI-DBLE LEAD CORT 5.0X44MM SCR. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT WAS IMPLANTED WITH AN ANKLE LOCKING NAIL. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY TWO MONTHS LATER DUE TO PAIN CAUSED BY A FRACTURED NAIL SEEN ON X-RAY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508761 ANKLE LOCKING NAIL 11 X 180MM X 180MM PROSTHESIS, TRAUMA HSB ZIMMER BIOMET, INC. N/A 249840 00887868093609

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE