BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANN PH NAIL LT 7X260MM

    MDR report key: 22135378 · Received June 3, 2025

    Report

    Report Number
    0009613350-2025-00394
    Event Type
    Injury
    Date Received
    June 3, 2025
    Date of Event
    June 27, 2023
    Report Date
    August 15, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    UDI-DI
    00889024506046
    PMA / PMN Number
    K231114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CORTICAL BONE SCREW, #ITEM 47248612440, #LOT 3082058. CORTICAL BONE SCREW, #ITEM 47248612440, #LOT 3139152. CORTICAL BONE SCREW, #ITEM 47248613840, #LOT 3024647. BLUNT TIP SCREW, #ITEM 47248603840, #LOT 3147821. BLUNT TIP SCREW, #ITEM 47248604040, #LOT 3078175. BLUNT TIP SCREW, #ITEM 47248603640, #LOT 3076827. THERAPY DATE: (B)(6) 2023. G2: FOREIGN COUNTRY BELGIUM. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. 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

    FOLLOW UP REPORT (B)(4). NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION 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 COULD NOT BE DETERMINED. 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 THE PATIENT UNDERWENT A REVISION 5 DAYS POST-IMPLANTATION DUE TO A FRACTURE OF THE PROXIMAL AND DISTAL HUMERUS. THE PATIENT IS REPORTED AS IMPROVED/RECUPERATED 6 MONTHS POST REVISION. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065100 ANN PH NAIL LT 7X260MM IMPLANT, TRAUMA HSB ZIMMER GMBH 3068502 00889024506046

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Hospitalization| R SEE H11 NARRATIVE.