BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANN BLUNT TIP SCREW 4X46MM

    MDR report key: 23123043 · Received September 23, 2025

    Report

    Report Number
    0009613350-2025-00724
    Event Type
    Malfunction
    Date Received
    September 23, 2025
    Date of Event
    August 19, 2025
    Report Date
    February 26, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    PMA / PMN Number
    K231114
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 PRODUCTS WERE RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEMS AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATIONS. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. THE REVIEW IDENTIFIED AN INTRAMEDULLARY NAIL FIXATION FOR RIGHT PROXIMAL HUMERUS FRACTURE. THE FIRST FOLLOW-UP VISIT SHOWS BACKOUT/LOOSENING OF TWO OF THE THREE PROXIMAL HUMERUS SCREWS. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D4. PRODUCT ID WAS PROVIDED FOR THREE SCREWS; HOWEVER, IT IS UNKNOWN WHICH 2 OF THE 3 SCREWS WERE MIGRATED. THEREFORE, THE MIGRATED SCREW COULD BE ANY OF THE FOLLOWING: 47248604640 ¿ BLUNT TIP SCREW ¿ 3230185. UDI: (B)(4). MANUFACTURING DATE: FEB 24, 2025. EXPIRATION DATE: FEB 24, 2030. 47248604640 ¿ BLUNT TIP SCREW ¿ 3231639. UDI: (B)(4). MANUFACTURING DATE: MAR 4, 2025. EXPIRATION DATE: MAR 4, 2030. 47248604840 ¿ BLUNT TIP SCREW - 3212560. UDI: (B)(4). MANUFACTURING DATE: AUG 24, 2024. EXPIRATION DATE: AUG 24, 2029. D10. ANN PH NAIL RT 10X240MM ITEM# 47249624009 LOT# 3216539. ANN BLUNT TIP SCREW 4X46MM ITEM# 47248604640 LOT# 3231639. ANN BLUNT TIP SCREW 4X48MM ITEM# 47248604840 LOT# 3212560. CORTICAL BONE SCREW, ÿ 4X24MM ITEM# 47248612440 LOT# 3237328. CORTICAL BONE SCREW, ÿ 4X26MM ITEM# 47248612640 LOT# 3235324. PROXIMAL HUMERUS NAIL CAP, ÿ 10.5X2.5MM ITEM# 47248801002 LOT# 3238880. 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 WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OPERATION WAS PERFORMED WITH ANN NAIL AND SUBSEQUENTLY, 22 DAYS LATER, SURGEON FOUND TWO OF THE PROXIMAL SCREWS WERE BACKED OUT FROM THE PROPER POSITION. THE SURGEON KEEPS AN EYE ON THE PATIENT CONDITION AS WELL AS NO REVISION WILL BE PLANNED SO FAR. 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
    942187 ANN BLUNT TIP SCREW 4X46MM IMPLANT, TRAUMA HSB ZIMMER GMBH 3230185

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female