BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUNT TIP SCREW, ÿ 4X46MM

    MDR report key: 21920474 · Received April 28, 2025

    Report

    Report Number
    0009613350-2025-00347
    Event Type
    Injury
    Date Received
    April 28, 2025
    Date of Event
    November 3, 2023
    Report Date
    October 16, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    UDI-DI
    00889024505476
    PMA / PMN Number
    K200814
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4. PRODUCT ID WAS PROVIDED FOR 3 SCREWS; HOWEVER, IT IS UNKNOWN WHICH OF THE 3 SCREWS HAS MIGRATED. THEREFORE, THE MIGRATED SCREW COULD BE ANY OF THE FOLLOWING: 47248604640 ¿ BLUNT TIP SCREW ¿ (B)(6). UDI: (B)(4). MANUFACTURING DATE: APR 8, 2021. EXPIRATION DATE: MAR 31, 2026. 47248604840 ¿ BLUNT TIP SCREW ¿ (B)(6). UDI: (B)(4). MANUFACTURING DATE: JAN 6, 2020. EXPIRATION DATE: DEC 31, 2024. 47248604440 ¿ BLUNT TIP SCREW ¿ (B)(6). UDI: (B)(4). MANUFACTURING DATE: MAY 4, 2023. EXPIRATION DATE: MAY 4, 2028. D10. PROXIMAL HUMERUS, RIGHT, LONG, ÿ 8.5X260MM ITEM# 47249626008 LOT#3143465. BLUNT TIP SCREW, ÿ 4X48MM ITEM# 47248604840 LOT# 3008269. BLUNT TIP SCREW, ÿ 4X44MM ITEM# 47248604440 LOT# 3157872. CORTICAL BONE SCREW, ÿ 4X28MM ITEM# 47248612840 LOT# 3073713. CORTICAL BONE SCREW, ÿ 4X28MM ITEM# 47248612840 LOT# 3078236. G2. REPORT SOURCE: SWITZERLAND. 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 WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H3, H6, H10, H11. 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 HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEMS AND THE PART AND LOT COMBINATIONS. COMPLAINTS ARE MONITORED PER COMPLAINT TRENDING PROCESS IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. LOOSE SCREW DETECTED AT 3-MONTH FOLLOW-UP. HOWEVER, THERE ARE NO FURTHER DOCUMENTS AVAILABLE THAT COULD CONFIRM THIS. AS THE DEVICES INVOLVED IN THE REPORTED EVENT WERE NOT RETURNED FOR INVESTIGATION, A FURTHER PRODUCT EVALUATION COULD NOT BE PERFORMED AND THE CONDITION OF THE PRODUCTS ARE UNKNOWN. IN CONCLUSION, AS THE CAUSE MAY BE MULTIFACTORIAL, AN EXACT ROOT CAUSE COULD NOT BE IDENTIFIED. 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 THE PATIENT WAS ORIGINALLY IMPLANTED WITH THE AFFIXUS HUMERAL NAIL. SUBSEQUENTLY, APPROXIMATELY 4 MONTHS POST IMPLANTATION, UNDERWENT A REVISION SURGERY DUE TO LOOSENING OF ONE OF THE SCREWS. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1582065 BLUNT TIP SCREW, ÿ 4X46MM IMPLANT, TRAUMA HRS ZIMMER GMBH 3068474 00889024505476

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention| H SEE H11 NARRATIVE.