BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Z NAIL CMF 13MM X 32CM 125 L

    MDR report key: 20053916 · Received August 23, 2024

    Report

    Report Number
    0009613350-2024-00399
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    July 30, 2024
    Report Date
    November 15, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    UDI-DI
    00889024586260
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM # 47249908010, Z NAIL CMF 10.5 X 80 LAG SCR, LOT # 3182476. ITEM # 47248403050, Z NAIL 5.0X30 CORT SCREW FA, LOT # 66328454. ITEM # 47248403250, Z NAIL 5.0X32.5 CORT SCREW FA, LOT # 66087384. ITEM # 47250000200, Z NAIL CMF NAIL CAP 0MM, LOT # 3185239. ITEM # 47250106050, Z NAIL CMF 5.0X60 ANT SUP SCR, LOT # 3087613. G2: REPORT SOURCE JAPAN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H3, H6, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CANNOT BE CONFIRMED AND A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION APPROXIMATELY 3 MONTHS POST IMPLANTATION. ONE WEEK AFTER SURGERY, THE REPOSITIONING POSITION WAS COLLAPSED, AND THE LAG SCREW BEGAN TO MOVE. THE LAG SCREW CONTINUED TO PULL OUT, AND EVENTUALLY THE LAG SCREW PULLED OUT OF THE NAIL. ALL THE ORIGINALLY IMPLANTED IMPLANTS WERE 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
    1582323 Z NAIL CMF 13MM X 32CM 125 L TRAUMA, INSTRUMENTS. HSB ZIMMER GMBH N/A 3068036 00889024586260

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11 NARRATIVE.